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The Flex Scoring Catheter (From Ventura Med): A Simple Cost-Effective Method For Lesion Preparation Prior To DCB Use: How It Works, Advantages And Early Results
The Flex Scoring Catheter (From Ventura Med): A Simple Cost-Effective Method For Lesion Preparation Prior To DCB Use: How It Works, Advantages And Early Results
ballooncalcificationcatheterchroniccircumferentialcompliancectosdedicateddevicedissectionsfemoropoplitealFistulaflexincisionsinterventionallengthlesionluminalmoderateocclusionpoplitealscoringScoring catheter for vessel preparationshaftstenttherapeuticVentureMed Groupvessel
CME
The Serranator Balloon Catheter (From Cagent Vascular) To Score Lesions, Facilitate Their Dilatation Without Dissection And Possibly Improve Drug Delivery: How It Works And Results Of The PRELUDE Trial
The Serranator Balloon Catheter (From Cagent Vascular) To Score Lesions, Facilitate Their Dilatation Without Dissection And Possibly Improve Drug Delivery: How It Works And Results Of The PRELUDE Trial
adjudicatedangiographicarteryassessbailoutballoonCagent MedicalcalcificationcalcifiedclassificationclaudicantcoredevicediameterdissectionseffectiveendoluminalendpointendpointsenrollingenrollmentfeasibilityivuslesionlumenmoderateneointimaloutcomespatencypathologicpoplitealprimaryPTA serration balloon catheterresistiverutherfordscoringSerrenator altoseverestenosisstentstentedstentingstudysuperficialtherapeutic
CME
The Vanguard IEP Balloon PTA System With An Integrated Embolic Protection Filter: How It Works And When It Should Be Used
The Vanguard IEP Balloon PTA System With An Integrated Embolic Protection Filter: How It Works And When It Should Be Used
acuteangioplastyanteriorballoonBalloon angioplasty systembifurcationcapturecapturedchronicContego MedicaldebrisdevicedistalembolicembolizationlesionlesionslimboccludedocclusionplanarpoplitealreocclusionriskrotationalrunoffstentstentstherapeutictibialtotalulcerationVanguard IEPvessel
CME
The Tigris Dual Component Stent (From Gore): Advantages And 1-Year Results In Treating SFA-Pop Occlusive Lesions: From The Austrian Registry
The Tigris Dual Component Stent (From Gore): Advantages And 1-Year Results In Treating SFA-Pop Occlusive Lesions: From The Austrian Registry
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CME
More About The Value And Limitations Of The Tigris Dual Component Stent For SFA-Pop Lesion Treatment: What Makes It Different
More About The Value And Limitations Of The Tigris Dual Component Stent For SFA-Pop Lesion Treatment: What Makes It Different
arterycompressionconsistentdeviceelongationendpointevaluateevargoreGORE MedicalinterventionalischemialesionlimbocclusionpatencypatientpatientspercutaneousperipheralpoplitealprimarysalvagesecondarystenttherapeuticTigristreatedtreatmentVascular stentvessel
CME
Update On The Value Of The Bullfrog Catheter (From Mercator Medical Systems) To Infuse Dexamethasone Into The Adventitia Of Lesions: Status And Results Of The DANCE Trial And The LIMBO-ATX RCT In Patients With CLTI Due To BTK Lesions
Update On The Value Of The Bullfrog Catheter (From Mercator Medical Systems) To Infuse Dexamethasone Into The Adventitia Of Lesions: Status And Results Of The DANCE Trial And The LIMBO-ATX RCT In Patients With CLTI Due To BTK Lesions
adventitialangiographicangioplastyatherectomyballoonballoonsbiologiccalcificationcascadedeliverydemographicsdevicedexamethasonedrugdrug elutingelutingenrollingenrollmentinflammatorykneelimuslosslumenmedialMercator MedsystemsMicroinfusion deviceneointimalpatencypoplitealprimaryproliferationrestenoticrutherfordsignalingstentstentstemsirolimustermsThe Bullfrogtherapeutictherapiestranslatetrials
CME
Update On The Value Of Tack Assisted Balloon Angioplasty (TOBA) : Results Of The TOBA II Study
Update On The Value Of Tack Assisted Balloon Angioplasty (TOBA) : Results Of The TOBA II Study
adjudicatedanchoringbailoutclinicaldissecteddissectionDissection repair devicedissectionsefficacyendovascularenrollenrolledfreedomimplantimprovementIntact MedicallengthlesionlesionsnitinolpatencypatientsPOBAprimaryradiopaqueregardrestenoticstenosisstentTack endovascular systemtargettherapeuticvessel
CME
The Advantages Of The BioMimics 3D Helical Swirling Flow Stent (Veryan Medical): How It Works And Why It Is Better Than Straight Stents
The Advantages Of The BioMimics 3D Helical Swirling Flow Stent (Veryan Medical): How It Works And Why It Is Better Than Straight Stents
3D Vascular biomimetic stentarteryatherosclerosisbiomechanicalBiomimics 3D vascular stentcadavercarotidconfigurationfemoralflowfracturehelicalhyperplasiailiacintimalkinknitinolpatencypoplitealporcineproximalrandomizedrestenosisshearstentstraightsuperficialtherapeuticventricleVeryan Medicalwall
CME
Update On The BioMimics 3D Helical Swirling Flow Stent: The MIMICS-2 Trial Results Show It Works Well With Complex Lesions (CTOs, Heavy Calcification And Long Lesions)
Update On The BioMimics 3D Helical Swirling Flow Stent: The MIMICS-2 Trial Results Show It Works Well With Complex Lesions (CTOs, Heavy Calcification And Long Lesions)
3D Vascular biomimetic stentbailoutbiomechanicalBiomimics 3D vascular stentcalcificationcalcifiedchallengingclinicallycodedcomparingctosdatadrivendrugfreedomhelicallesionlossmoderatepatencypatientsprimaryrandomizedrateregistriesreinterventionseverestentstentedstentingsubstantialsuggestedtherapeuticVeryan Medical
CME
Progress In Developing A Site Specific Self-Expanding DES For Use In The Crural Arteries: The SAVAL Trial
Progress In Developing A Site Specific Self-Expanding DES For Use In The Crural Arteries: The SAVAL Trial
amputationanatomyangioangioplastyballoonbiologicalBoston ScientificcentersclinicaldrugDrug eluting vascular stentelutingendovascularenrollmentevarexpandableexpandingglobalhemodynamicischemiakneelesionlesionsmetanakamuranitinolocclusionpatencypercutaneousperspectivepivotalprimaryproximalrandomizerecoilreinterventionrestenosisscaffoldstentstentingstudyThe Savaltherapeutictibial
CME
Preclinical Evaluation of a New Generation DCB
Preclinical Evaluation of a New Generation DCB
arterialballoonbenchmarkbiologicalcoatingcompareddownstreamdrugDrug coated balloneffectsemboliembolicendothelialevarfibrinintimaintimalmedialpaclitaxelparticulatepreclinicalproprietarySurModicsSurveil DCBtherapeuticvisible
Transcript

- The FLEX Scoring Catheter is one of the new tools, which is dedicated to vessel preparation, either as a stent, as a therapy followed by plain balloon angioplasty, or preparing the vessel for drug-eluting balloons and stents. So, the background basically is that

we're more and more tackling chronic total occlusions, and these kind of lesions, they have an increased risk of being calcium-containing, creating dissections, perforations, embolization, and poor luminal gain. And for that purpose, this device, which is more or less

a kind of surgical device, was developed. It's a interventional tool which can be introduced via a six-French sheath. It's an over-the-wire system, running over a 14 or 18 thousandths guide wire. It's common in shaft lengths of

40 centimeters dedicated to AV, fistula treatment and 120 centimeters, and the device is exposed to the vessel wall with three atherotomes, with the indication for femoropopiliteal and AV fistula excess treatment. One size fits all is really the right description

of this device, except having two different shaft lengths, the device itself is coming in one size only. What does it result in? Well, it results in micro-incisions, as you can see it over here, also over here in an OCT image, and the depths of these incisions

is about 0.5 millimeters, the pressure which is applied to the surface is about one atmosphere, independent on the vessel size. So, the idea and the rationale for this device is to facilitate and increase the vessel compliance and to create an controlled environment for angioplasty.

There are, just recently, some specimen analysis performed by CBSET, what you can see over here, marked by arrows, these arrows indicate the FLEX-induced micro-incisions, and you can see that these incisions are really circumferential with controlled,

uniform depths of those incisions into the plaque or the vessel wall. This is a 150 times magnification and you can see these longitudinal micro-incisions, which are very much parallel, it's like using a cutting balloon,

the advantage, however, is that this device can be applied to even longer lesions, the limitation of a cutting balloon is the balloon length of 20 centimeters only. So what are the early results? I can present you the acute outcomes

of 100 patients' sample size, with chronic total femoropopliteal occlusions. We can see that the average lesion length was really significant, 191 millimeters, the range was up to 35 centimeters, and there was moderate to severe calcification

in almost 50% of those cases. The luminal gain post FLEX application was about 31%, and the following balloon opening pressure, which was documented within this registry, was four atmospheres only, which is a signal that really the vessel compliance

is significantly improved, considering the almost 50% of moderate to severe calcification of those lesions. There had been no emboli, there had been no flow-limiting dissections, nevertheless, the provisional stent use was still high with 19%.

This is one of two case examples I would like to share with you. This was an instant re-occlusion of the popliteal artery, 10 centimeters in length, this was passed with an 18 thousandths guide wire, three passes with the FLEX catheter had been performed,

as you can see over here. And this was then, this was the result after FLEX catheter application and this is post additional drug-coated balloon angioplasty, there was no dissection, there was no significant residual stenosis.

Another case example, unfortunately, the video will not run, this was a long distance flush occlusion of the SFA, and you can see the calcium here in the entire length of the lesion, this lesion was treated, again, with the FLEX catheter, here, the video is not running,

this is the final result after DCB application. So, in summary, there's a high degree of technical success in achieving consistent luminal gain post FLEX, there's a low opening balloon pressure, and the re-canalization of CTOs was possible with a low rate, zero rate of significant dissections

and the low provisional stent rate. Thank you very much.

- Yeah, I'm going to talk about the Serranator Ballon Catheter, in the PRELUDE Trial. I'm a consultant to Cagent, I served on their CEC. So this is the Serranator PTA Balloon Catheter. It's a focal force catheter with a, designed to create linear, interrupted scoring along the endoluminal surface.

There are four embedded, strips along the nylon balloon, which is semi-compliant. You can here the size matrix, four, five, and six. At lengths up to 120, And this is the balloon that we'll be talking about for the trial.

The concept here is that serrated vessel will have more responsiveness to balloon dilation. And that's evident here. There is from the Serranator, from the PRELUDE Trial itself. You can see that this OCT and in this IVUS, that there are clear cuts in the vessel, from the Serranator

and in a pathologic specimen from CBSET, there's clear fracturing of the calcium, as well as the superficial neointimal lacerations. All of which are intended to both promote balloon dilation in a more controlled fashion, but also address resistive lesions, and potentially

create reservoirs for drug uptake. So the prelude study overview is here. It's a single arm, prospective, multi-center feasibility study enrolling up to 30 patients with superficial femoral popliteal artery disease. Follow up was 30 days and six months.

The enrollment was completed over a year ago, and the study ended about a year ago in terms of follow up. Investigators are listed here. I adjudicated the outcomes. You can see the Core Labs here.

So a very well done study with Core Lab independent adjudication. Primary objective was to assess the technical feasibility of the Serranator creating these, in critical SFA and popliteal artery lesions. And to assess the OCT and IVUS feasibility

in a sub-set of these patients. To look for the evidence of serration. Primary endpoints, typical safety endpoints. The efficacy endpoint is a device, is defined as device success. Which is successful balloon delivery, retrieval,

inflation/deflation, and a final diameter stenosis of less than 50%. Key secondary endpoints are here. Core Lab assessment of pre-procedure and post-procedure angiography. Patency.

As determined by duplex ultrasound. And TLR and TVR at 30 days and six months. Here are the inclusion criteria. Really nothing too unique here. The lesion length was described as less than or equal to 10 centimeters.

No stented lesions. And exclusion criteria. No CTO's greater than six centimeters, or severe calcification. Here are the patient demographics. A really remarkable here are the presence of diabetes,

in approximately a third of the patients. And Rutherford classification, really defining a claudicant population. Here are the angiographic descriptors. The lesion length was about five centimeters. There were about a third of the patients with CTOs,

and moderate to severe calcification over half of the patients. The pre-procedure diameter stenosis was 88%, and that was reduced to 23% post-procedure, and the bailout stenting and flow limiting dissections were incredibly low, with only one bailout stent

in a spiral dissection from a CTO. As mentioned previously, there was a very pleasing reduction in overall stenosis severity, in a moderate lesion set. From 88% to about 23%, and the primary endpoint of device success was achieved in 100% of the patients.

With successful placement, inflation/deflation, and retrieval, and reduction in stenosis severity of less than 50%. If we now break down the outcomes according to calcified and non-calcified vessels to really assess whether or not the serranation was working,

you can see that the severe calcification and mild to moderate calcification, that there's no real difference in mean lumen gain, or in atmospheric pressure requirements for dilation. Suggesting that the Serranator is actually effective as intended.

A couple of case examples. You can see the severe calcification here in this distal SFA. And after a single Serranator treatment, you can see a significant reduction, and management of that calcium.

Here it is in the popliteal artery. A notorious area for dissection. Especially in total occlusions. And you can see that after a passage of wire and Serranator balloon, very pleasing result without significant dissection.

Safety outcomes were excellent. No adverse events. No deaths. One SAE not related to the device. Clinical outcomes were also pleasing. There was a shift from Rutherford classification

2 and 3 primarily, to classification 0 and 1 primarily. So in conclusion, the study objectives and primary endpoints were achieved. The Serranator has been shown to be safe and effective in treating critical femoro-popliteal lesions. With 100% device success.

With acute results showing a mean residual stenosis that was lower than 25%. 100% patency at 30 days. 100% freedom from TLR at 30 days and six months. And 100% serration effect demonstrated in the sub-group which had OCT and IVUS assessment.

It was equally effective in lumen gain in both moderate and severely calcified lesions, suggesting the Serranator effect. Thank you very much.

- Yeah now, I'm talking about another kind of vessel preparation device, which is dedicated to prevent the occurrence of embolic events and with these complications. That's a very typical appearance of an occluded stent with appositional stent thrombosis up to the femur bifurcation.

If you treat such a lesion simply with balloon angioplasty, you will frequently see some embolic debris going downstream, residing in this total occlusion of the distal pocket heel artery as a result of an embolus, which is fixed at the bifurcation of

the anterior tibial and the tibial planar trunk, what you can see over here. So rates of macro embolization have been described as high as 38% after femoral popliteal angioplasty. It can be associated with limb loss.

There is a risk of limb loss may be higher in patients suffering from poor run-off and critical limb ischemia. There is a higher rate of embolization for in-stent restenosis, in particular, in occluded stents and chronic total occlusions.

There is a higher rate of cause and longer lesions. This is the Vanguard IEP system. It's an integrated balloon angioplasty and embolic protection device. You can see over here, the handle. There is a rotational knob, where you can,

a top knob where you can deploy, and recapture the filter. This is the balloon, which is coming into diameters and three different lengths. This is the filter, 60 millimeter in length. The pore size is 150 micron,

which is sufficient enough to capture relevant debris going downstream. The device is running over an 80,000 or 14,000 guide-wire. This is a short animation about how the device does work. It's basically like a traditional balloon.

So first of all, we have to cross the lesion with a guide-wire. After that, the device can be inserted. It's not necessary to pre-dilate the lesion due to the lower profile of the capture balloon. So first of all, the capture filter,

the filter is exposed to the vessel wall. Then you perform your pre-dilatation or your dilatation. You have to wait a couple of second until the full deflation of the balloon, and then you recapture the filter, and remove the embolic debris.

So when to use it? Well, at higher risk for embolization, I already mentioned, which kind of lesions are at risk and at higher risk of clinical consequences that should come if embolization will occur. Here visible thrombus, acute limb ischemia,

chronic total occlusion, ulceration and calcification, large plaque volume and in-stent reocclusion of course. The ENTRAP Study was just recently finished. Regarding enrollment, more than 100 patients had been enrolled. I will share with you now the results

of an interim analysis of the first 50 patients. It's a prospective multi-center, non-randomized single-arm study with 30-day safety, and acute performance follow-up. The objective was to provide post-market data in the European Union to provide support for FDA clearance.

This is the balloon as you have seen already. It's coming in five and six millimeter diameter, and in lengths of 80, 120 and 200 millimeters. This is now the primary safety end point at 30 days. 53 subjects had been enrolled. There was no event.

So the safety composite end point was reached in 100%. The device success was also 100%. So all those lesions that had been intended to be treated could be approached with the device. The device could be removed successfully. This is a case example with short lesion

of the distal SFA. This is the device in place. That's the result after intervention. That's the debris which was captured inside the filter. Some more case examples of more massive debris captured in the tip of the filter,

in particular, in longer distance total occlusions. Even if this is not a total occlusion, you may see later on that in this diffused long distance SFA lesion, significant debris was captured. Considering the size of this embolus,

if this would have been a patient under CLI conditions with a single runoff vessel, this would have potentially harmed the patient. Thank you very much.

- Thank you very much. We have prospectively analyzed 100 patients with the Tigris Stent in the SFA. Is there still a relevance for scaffolding in our leaving nothing behind paradigm? Drug Coated Balloons actually have have widely changed the way of of endovascular treatment of fem-pop lesions.

But they have one short coming. They provide no mechanical stabilization of the vessel wall. We can see in the randomized trials, DCB trials, that there's still a need of scaffolding in three to 15% of cases in short lesions. In long lesions, as you can see here,

for example, the lactic registry with a mean lesion length of 24 centimeters stent, bailout stent rate is even higher. So these data clearly show that there is a need for scaffolding in the everyday cath lab routine. And our treatment algorithm is that we predilate patients

if we see that they react nicely to predilatation they will be finally treated with a DCB. If we can see after predilatation that they are PTA non-responders if there is recoil or dissections, we treat them with a stent.

And that's a case example of a PTA responder short SFA lesion. After predilatation we already have a very nice result and this has been the result of the DCB treatment. A similar case of the focal stenosis, however you can see dissection recoil more than 50%.

This patient was treated with a stent. And we have analyzed these patients who have received the Tigris Stent. We used that stent specifically because it has some features that make it very appropriate for motion segments

in the distal SFA P1 segment. It is Nitinol frame interconnected with ePTFE structures. It is thereby very flexible, and allows compression and movement. Our patient cohort was 97 patients, 100 legs treated.

This was was a single center prospective trial. We included all patients with de novo or restenotic lesions with a maximum length of eight centimeters so we were able to treat them with one single scaffold. Patients characteristics were typical for this cohort, mostly male patients, a lot of smokers.

The lesion characteristic were as follows. You can see about 56%, more than half of patients were in the motion segment, in the distal SFA and popliteal artery and lesion length was short with 5.6 centimeters, ranging from two to eight.

There were no device related complications, and a few procedure related complication. And a 12 month follow-up was available for 98 patients. Two patients, one patient was lost to follow-up for unknown reasons, and one patient died from coronary artery disease.

This is the clinical improvement. As you can see, before intervention, the red bars, most patients were claudicants. After intervention, at 12 months most patients were symptom free. Clinical improvement was evident in more than 90% of cases.

This is also reflected by ABI measurements which were good throughout the one year follow-up, improving from 0.7 to 0.9. The primary endpoint was primary patency. We had 91 patients patent after a year, only seven patients with restenosis or reocclusions

and therefore the freedom from TLR was also very high with more than 94%. This is the Kaplan-Meier analysis of these endpoints. 12 months primary patency 92%. Freedom from TLR after a year, almost 95%. And all patients who had a restenosis

were also treated successfully. So we have 100% secondary patency. So to summarize this data, we saw in that we're a special setting that we treat patients who were PTA non-responders, that we had a very good patency with the Tigris Stent.

Also in the distal SFA and the P1 segment, this proved to be a very safe and also efficient method and we will continue follow-up to assess the long-term patency. Thank you.

- [Female Speaker] Thank you, good afternoon. Thank you, chairman. These are my disclosure. So, Tigris stent was only recently approval in USA for the treatment of SFA and peripheral artery. In Europe we have the same study in 2011 and what means its different from other stent

as already reported is very special design. It's a single ended precision delivery and 100% of the stent could be deployed within the nominal length. What make it different, again, the elongation testing show a minimal elongation rate so it decrease

the potential for stent fracture. The straightening force testing showed less straightening force and the longitudinal compression test, less resistance to compression leading to a high conformability of the vessel wall. As all the GORE product is a proven

CBAS Heparin Surface technology. In order to evaluate what it was the peripheral (unintelligible) in our patient during this years, we started a physician initiated, prospective, multi-centre, single arm registry,

collecting data from eight centers. In Italy, four interventional radiology units and four vascular surgeon to evaluate the feasibility and safety of this device in the treatment of this SFA with or without femoro-popliteal when using siding structure for use.

So the primary endpoint was the primary patency at 12 months. These are presumably our results based on 121 patients. The lesion length was around 13 centimeters and according to Rutherford classification

60% of the patients are at critical limb ischemia In location of the stent was mainly in the SFA and 24% of the cases in the motion zone and popliteal artery was involvement of popliteal arteries were present in 18% of the patients. And in half of them we have a complete

occlusion of the popliteal artery. Most of the cases there's only one vessel run off, this is one where the patient has been treated. This is a group with a long (indecipherable) dissection of the PTA which was treated with

2 Gore Tigris stents. The preliminary results of one month show a technical success in all the patients. We have a primary patency of 98.3% and a secondary patency of 99.2% 6 months we have a primary patency of 86.6%

and a secondary patency of 91.7% 5 patients who have been treated percutaneous 2 patients underwent bypass. Only 1 patient had an amputation within the limb salvage rate of 99% At 12 months the result are a still good

according to the primary patency of 87.1% of a patency. Secondary was 88.2% and limb salvage is always 99% If you compare these results to what reports are already written in literature

we see that the lesion length was similar to other studies and we have always treated SFA and treated as well SFA and the popliteal artery. The percentage of chronic ischemia is consistent with the other study and we have

a good results consistent with this other report already. So my conclusion are this device could be safely used in the treatment of SFA and popliteal artery and even in case of a bail out stenting.

Of course only longer follow up and a higher number of patients could tell us if this could work even in longer and very complex lesions. Thank you.

- So, Drug Eluting Technologies, a very exciting piece for Preferential Disease. If you can think about it, you know, ultimately in the future maybe we can personalize care depending on what kind of demographics the patient has, where the lesion is, what type of plaque morphology, etcetera.

But it all revolves around the inflammatory cascade issue, you see here, and currently we're targeting different parts of this cascade whether it be signaling, recruitment, proliferation, or hyperplasia/narrowing. We've talked a lot about drug-coated balloons, right,

and it prevents Neointimal Hyperplasia, but how about direct drug delivery with a Bullfrog device. And what, I'll show you a pictorial in a second about exactly how it works, but this is a device that you can deliver different types of biologics to

and ultimately you can see where it's being delivered. As you can see here, it's a microneedle between two balloons, the balloons open, push off the back wall, the microneedle goes in, you can inject the biologic of choice, right.

And you can mix it with some dye such that you can actually see it go into the mediaadventitia of the vessel to maybe prevent smooth muscle cell proliferation for example. So, currently in the pipeline,

with the bullfrog device and mercater, we've looked at antirecoil biologics, such as vanapanitase, antiinflammatories such as dexamethasone, and then antineoprolifatives such as Temsirolimus. I also tell you that we're looking at combinations of therapies as well as stem cells in the future.

You can see the row of different clinical trials so focus of this talk is the DANCE trial. The 12 month results this was an above the knee trial injecting dexamethasone using either atherectomy or balloon angioplasty. The results as you can see here below

compare to plain old balloon angioplasty above the knee it seemed to be superior in terms of 12 month primary patency rates and if you look at drug coated balloons it looked to be possibly non inferior to those results. After two years the atherectomy arm of DANCE

was 72.2% in terms of primary patency, compared to DANCE balloon angioplasty, and what that means is balloon angioplasty followed by direct delivery with dexamethasone, it was 68.9%. So then how do we translate from going above the knee to below the knee in the LIMBO trials?

If you look at the demagraphics of the DANCE trial, significant group of people that were diabetic, at least half in both arms, severe calcification which ranged between 20-30%, popliteal involvement somewhere between 16 and 19%. And as you can see to the right in terms

of the atherectomy arm, severe calcium in terms of patency after 24 months, 80.3% versus the balloon angioplasty arm which was 72.1, popliteal 88% to 69.2%. Looking at some of these demographics and how it fared then we translate it to below the knee understanding that we have a high burden of medial calcium.

One of the interesting things is in terms of outcomes which is been a lot of discussion with different industries and different physicians especially below the knee. We came up with a pretty creative way to follow re-stenosis. And we came up with TVAL instead of late lumen loss

because late lumen loss just takes a specific point in time using different biologic therapies its shown us that you get more of a diffuse restenotic than just a point in time so we actually calculate the area rather than just late lumen loss called TVAL. So in the LIMBO study, two arms,

the US was atherectomy with LIMBO with dexamethasone below the knee. Europe plain old balloon angioplasty with dexamathasone as you can see here enrolling both Rutherford four five and Rutherford six and following six month angiographic TVAL.

The next study and that's just currently ended enrollment and we're looking at the data. The next one is a combination of two drugs, limus and an antiinflammatory, or actually just limus just using limus and the preface for that is with

the drug eluting stent trials that have been done below the knee using a limus drug, and what we found is with in comparison to the Xience V Everolimus to Bullfrog Temsirolimus Tissue Concentrations are very similar.

Again, now going to twist TWIST saying a combination of drugs does that offer an additional benefit? And so if you look at it, what would happen in the inflammatory cascade you would actually block three signaling pathways, signaling, recruitment,

and proliferation out of the inflammatory cascade. So in summary and conclusion, the addition of DEX procedure in DANCE has produced positive long term results in both primary atherectomy and primary angioplasty intervention that should translate well in below the knee lesions.

The well known limus drugs have performed well in coronary drug eluting stents for years, which should translate to below the knee space. Adventitial drug delivery opens the door for a variety of therapeutic applications, including patient specific therapy

or polypharmacy approaches. Thank you very much.

- So I have the honor to provide you with the 12-month result of the TOBA II trial. I guess we all confirmed that this action is the primary mechanism of angioplasty. We all know that lesions of dissection have a TLR rate of 3.5 times higher than lesions without dissection.

The current tools for dissection repair, these are stents. They have limitations, really a large metal load left behind causing inflammation. This is leading to in-stent restenosis. So the Tack Endovascular System.

It's a delivery system over six French catheter. This is for above the knee with six implants pre-loaded on a single catheter. The Tack implant itself, it has an adaptive sizing, so it adapts to the diameter of the vessel from 2.6 up to 6.0 for SFA and PPA usage.

It's a nitinol implant with gold radiopaque markers for visibility. Has a unique anchoring system, which prevents migration, and a deck which is deployed in six millimeter in length. So with regard to the TOBA II study design,

this was a prospective multi-center single-arm non-blinded study at 33 sites in US and Europe. We enrolled 213 subjects. These were all subjects with post-PTA dissection. So only with a dissection visible on the angiogram, the patients could be enrolled into this study.

We had the usually primary safety end point, primary efficacy end points, which we are familiar from other trials and other studies so far. With regard to the inclusion criteria, I just want to look at this very briefly.

Mainly we had de novo or non-stented restenotic lesions in the SFA P1. If it was a stenosis, the lesion length could be up to 150 millimeter. If it was a total occlusion, the length was up to 10 centimeters.

They had to be the presence of at least one target run of vessel to the foot. They had to be a post residual, post-PTA residual stenosis of lower than 30%, and the presence of at least one dissection Grade A to F. With regard to the key lesion characteristics,

baseline for the different patients, there was not a big difference to other studies out there. The only difference was maybe we had slightly more patients with diabetes. The lesion, the target lesion length, the mean target lesion length was up to 74 millimeters.

We also had patients with calcification, mainly moderate but also some with severe calcification. There were two met the primary end points. The 30-day freedom from major adverse event, and also the primary efficacy end point at 12 months, which was a freedom from clinical driven TLR,

and freedom from core lab adjudicated duplex ultrasound derived binary restenosis. Now, with regard to patency in a patient cohort, where we really had 100% dissected vessel at 100% dissected vessel population, we had primary patency at 12-month of 79.3%

and a freedom clinical driven TLR of 86.5%. There was with regard to dissection severity, we had 369 total dissections we were treating. The number of dissections per subject was 1.8. The mean dissection length was two centimeters. So around 70% of subjects had a dissection of

Grade C or greater before using the Tack. In 92.1% of all dissections, this could be completely resolved with a Tack. With regard to the Tack stability and durability, in total, 871 Tacks have been deployed. So that was a number of 4.1 Tacks per subject.

The bailout stent rate was very low, just one. The freedom from Tack fracture at 12 months, 100%, and there was one minor Tack migration at 12 months with education by the core lab so the Tack was not seen at the same place as six months or 12 months before.

There was significant clinical improvement with Rutherford category improvement in 63%, which improved of up to two classes. There was also an improvement in ABI, walking impairment questionnaire. So just to conclude, TOBA II is a unique trial.

First to enroll 100% dissected vessels. Successfully met the primary efficacy and safety end points, and demonstrated the Tack is an efficient repair system for dissections after POBA or DCB with minimum metal left behind, low radial force, stable and durable design,

and preservation of future treatment options. There was only a very, very low bailout stent rate. This in combination with high patency rate and high freedom from clinical TLR. Thank you very much.

- I'll start out with a question for Dr. Adams about the Bullfrog catheter. So, Dr. Adams, technically, how do you do the procedure, how much do you inject into the adventitia of the vessel, can you give us, how many points of the compass do you need to do?

- So it's one needle, some advice, prep the vessel before, especially in calcific lesions, for the needle to actually poke through the vessel to get to the adventitia, usually it's .5ccs to one cc, is what you inject, and when you mix it, you mix it half and half

with a contrast, such that you can see it. When you inject it, it'll wrap the vessel and go about 20mm when it's a successful injection. If there is trouble penetrating the vessel because of calcium, then what I typically do is pull the balloon down and either go superior or inferior

a couple of millimeters and reinflate the balloon to try to penetrate. - Thank you. - He wasn't on our schedule. - Yeah I have a question for Dr. Brodman, one of the issues, of course, when you have a very

short stent is making sure you nail exactly where the dissection is, and I would assume that's not always easy, what do you think about if we had co-registration for IVAs in the periphery, the ability of that to perhaps better guide where we place these tags,

to make sure that we seal these dissections, do you think that would be helpful? - Yes, and you know when we started to treat our patients with the dek implants for the really early studies, we used OCTOI with guidance to look and get a

feeling where to place the dek. And to be honest, this was a very helpful learning and additional method, just to help us to seal the dissections in the right way, but I guess if IVAs would be more out there and people would be more used to

IVAs or whatever kind of additional imaging technique, than angiography, I think that would be helpful in any way. - And Dr. Ziller, with the IEP balloon, is that a single-use balloon, can you bring it back in after you've used it or is it one-time and out? - Well it's, as I remember right in the IFU

it's a single-use device, but in clinical reality you can use it definitely a couple of times, because you are completely re-capturing the filter. The profile is probably not any more as good as it was initially, before the first placement,

but still, if there is an area which deserves additional treatment, you can use it, and what you can do, definitely, is, if you have a lesion which is longer than 200 millimeters, which is the longest length of this balloon, you can inflate the balloon first at the distal

segment of the lesion, you can recapture the filter, you can pull back the device, inflate or expose the filter once again towards the vessel wall, and then inflate the balloon a second time, that's feasible. - Great, and Dr. Verner, one question for you,

with the GORE TIGRIS stent, on your charts, maybe I looked quickly as I was, my phone had a buzz at that moment, but did I see that it said "higher radial force than Supera"? - No, we didn't comment on radial force. - Okay, I saw something, I thought I might have

looked too quickly, I just wanted to ask. - I have a quick follow-up question for Professor Zeller, about the balloon with the distal protection, so we're aware that atherectomy creates distal emboli, and so I think most are using distal embolic protection

with that procedure, but I think most have assumed that in a lot of lesions with balloon angioplasty, that there's not a lot of distal emboli, but your data would suggest that maybe that's more of a problem than we realized.

- Well, the key question is what is significant embolization and are you looking very close into the outflow vessels before you perform a routine balloon angioplasty, usually it's not done, I almost know, any operator who's doing a careful DSA

in two planes before and after balloon angioplasty, if you would do it, you might find more embolic events than reported in the literature so far, and I personally, I would not promote the use of embolic protection device in every kind of lesion, even if,

theoretically, an embolic event can happen even in a short two centimeter-long lesion, if it's isolated, for example, if you see a thrombus formation already, but in longer lesions and CTOs, I definitely believe that there is a value in preventing significant distal embolization,

and in particular if you're talking about treatment of instant reocclusion there, typically you find a mixed composition of the occlusive material, which is on the one side neointimal, obviously, but there's also a significant amount of thrombus which is

more or less organized and likely to go downstream. - And I see we have two questions from the audience, and then I think we'll have to wrap this session up. - [Andy] 'kay, quick question, hi, Andy Blum, Chicago, actually two quick questions about the TAC device, what is the regulatory status of TAC now in the US,

and also why was it designed for a maximum of six millimeter vessels, because that's going to exclude a lot of us guys. - This was just... for the second part of the question, why it is designed up to six millimeter, this was chose the device we have,

right now really was tested in a trial, with regard to the regulatory status, it I guess will be for sure be approved by FDA for below-the-knee use within the next year, so this is what I know, I'm not familiar with the US regulatory status, but I guess

that will be the case, maybe Domaselum knows more, or? - No, I don't know more than this, thank you. - [Raj] Hi, Dr. Verner, this is Raj Provak from India, you know you talked about the TIGRIS, now, we also have the VIABAHN, and they are supposed to have very good, almost 70 to 75% patency rates at a year,

so how would you decide which one to use, and where? - Well, we restricted the use of TIGRIS stent in short collisions, in order to, it's a cost effective point of view that we don't want to use two or three stents in a long lesion when we have longer stents available,

so that's the differentiation, short lesions, TIGRIS, long lesions you could use a VIABAHN or a Supera. - So with that great session, guys, great presentations, we're going to have to call this session to an end and allow our next session.

- I'm going to talk briefly about why a helical stent is better than a straight stent. Those are my disclosures. So building on the basic science that came out of Imperial College in London since the 1970s, Veryan designed the helical stent, that imparts that helical structure

to the superficial femoral artery. And the stent, like any nitinol stent, is very easy to place. There are two principal forms of advantage. First of all, biomechanically, the stent was subjected to compression.

We all know now the complex forces that happen in the superficial femoral artery. A straight stent will compress, on average, at about 5% compression. The helical stent remains fracture free until about 14%, which is well passed physiological levels.

Sorry, is it possible to go back one? Thanks. Veryan also did some cadaver work, and this is a representation of the cadaver work. If you place a straight stent in the superficial femoral artery proximal popliteal then,

sorry, can we go back one? Yeah can we go back a slide please? Can we get, let's see if we've got video working. If you place a straight stent then not only does the stent kink and fracture but the artery below will kink as well because it doesn't allow for the foreshortening as needed

when you bend your knee. If you place a helical stent then that shortening can happen, you don't get the fractures, and you don't get the kinking. And after 6,000 implants there have been no recorded cases of fracture with this stent.

The other advantage is generating swirling flow. Now swirling flow is actually natural flow. Most of us think about flow as being laminar, faster in the middle than the outside. But actually swirling flow is what happens naturally because of the compression of the left ventricle

and the nonplanar configuration of the aortic arch and the branch vessels. That swirling flow generates a higher velocity on the peripheries and that increases the wall shear stress. And that's important because wall shear stress has been shown to affect both

restenosis and atherosclerosis. So you can map where atherosclerosis happens in vessels according to the wall shear stress, similar with restenosis. So low wall shear stress, more atherosclerosis and restenosis.

If you increase that wall shear stress, less atherosclerosis and less restenosis. And that goes some way to explaining the high prevalence of atherosclerosis and restenosis in the superficial femoral artery when compared to the aorta and iliac arteries.

The stent has been implanted now, as I say, in 6,000 people. And these are some images taken from the original MIMIC study. This is on knee flexion. Our engineers will take a map of the stent. Using computational fluid dynamics,

they will map the stent, look at the flow inside, and they can measure the wall shear. And you can see with swirling flow there's high wall shear on the peripheries. And when you map that using CAD then that wall shear is above the pathological level,

so should, in principle, be reflected by less restenosis. Similarly using CFD and duplex data, you can look at the flow in the straight stent or the helical stent. And the straight stent, as you'd imagine, you have laminar flow, but in the helical stent

you have swirling flow with the high wall shear stress. That is all well and good but at some stage you need to test it out. The initial testing was done in porcine model. The straight stent was placed in one carotid artery and the same stent but with the helical configuration

was placed in the other carotid artery, and the 30 days was 45% less intimal hyperplasia with the helical stent. A randomized trial was performed. The patients were randomized two to one to the helical stent versus a straight stent.

At two years there was significantly better patency with the helical stent than the straight stent, and you'll notice that between 12 and 24 months there was no clinically-driven TLR in the helical stent whereas there was the expected ongoing attrition with the straight stent.

The company built up on that initial randomized trial. They developed the MIMICS-2 trial, which Tim Sullivan's about to tell you about, which led to approval in the US and Japan and there's now global registry called MIMICS-3D. So in summary, it's designed to have

both biomechanical advantage and to produce swirling flow, which optimizes the wall shear stress. In a randomized trial it has been demonstrated to improve clinical outcomes compared to a straight stent. Thank you very much.

- And I present these on behalf of the MIMICS-2 investigators and Professor Zeller. These are my disclosures. So at discussed the helical flow stent, was in a randomized trial published by Dr.Zeller, compared to the so called best stent of the time, in a randomized fashion.

You can see from these data that substantial number of patients had occlusions. And patients with moderate to severe calcification and when comparing with other published studies in the literature, the Mimics RCT, looked at a substantially higher number of patients

with CTOs and with sever calcification. And as shown previously, the results suggested to substantial benefit of the study stent when compared to the controlled stent both at 12 and especially at 24 months. In terms of loss of primary patency,

and as one would expect an even higher rate when looking at clinically driven TLR. We'll now look briefly at the MIMICS-2 one year results. Patients had significant amounts of moderate or severe calcification, almost half of patients in these categories.

Lesion length as is shown here, these were substantial lesions. Stented segment length was typically greater than 10 centimeters in most patients. And not surprisingly, a 100% device success and a 100% technical success.

We're looking at the primary safety endpoint, it was achieved in 268 out of 269 patients. And looking at 12-month freedom from loss of primary patency in 83% of the patients really substantially good results in a really difficult group of patients with CTOs and severely calcified lesions.

Not surprisingly, the rate of clinically driven TLR, was less than primary patency so an 88% freedom from TLR again, in a very challenging group of patients. What I think is significant, is that as Dr.Gi-an suggested that the results out to a year are quite good

and when you look out to two and three years, there's really no loss of results. So the idea that high wall she-er is maintained over time in a very flexible stent with a helical design as suggested by these longer term results. And the heart of the matter of this presentation is,

how do patients with really challenging lesions do with this particular stent? When looking at core lab data regarding lesion calcification comparing non or mild versus moderate and severe, there's no difference out to two years. When looking at lesion length, comparing those greater

than a hundred millimeters with those less than a hundred millimeters, no difference in clinically driven TLR out to two years. And looking at CTOs, again, no difference out to two years. The stent performance well initially but also in the long term.

So in conclusion, the probability of freedom from loss of primary patency at 12 month to similar to drug eluding stent or drug coded balloons. These data suggest that less than one in 10 subjects require reintervention out to 2 years. And the outcome is independent of lesion complexity,

looking at lesion length, CTOs and patient with severe calcification. 0% stent fractures in the Dr. Zeller's RCT and in MIMICS-2. And with DCB global registries showing a bailout stent rate of between 28 and 35%,

I saw a presentation yesterday suggesting it was high as 40%. This stent provides haemodynamic, biomechanical and clinical benefits that are relevant both for primary stenting and for complementary bailout stenting

in patients who had needed following drug coded balloon therapy. Thank you.

- Thank you and thank Dr. Veith for giving me this opportunity to come again and speak to our increasing experience on this difficult sort of angulated area, vasculomimetic stents, the Supera, in the angulated areas other than the SFA. No disclosures.

That's the hospital that I work at. And apart from the SFA there are other areas which allow the Superas to be used across joints, across cavities, across curves. I mean, conforming to the angulations and flowing along the arteries,

the flexibility of the arteries, and avoiding kinks and fractures for the stents. So these ares challenges which are in the other non-SFA territories that one has to actually try and you are set up against. The Supera mimics the natural structure

and the movement of the anatomy fairly well. It has high radial strength as we all know. It is relatively kink resistant. And it stands up to the calcium. So the properties of the Supera that we've utilized in the non-fempop regions

are the, it's ease of conformability, its flexibility, and the mobility that it offers. So we've actually used the Supera off label in a number of non-SFA territories, the first being the brachial artery. This was gentleman who actually had a fractured elbow

and he had, subsequent to that, was someone had actually placed in a stent for continuity of his brachial artery. He had very poor overlying skin, and this stent occluded after about two years or so and we just did not want to enter the surgical option,

and here we actually outlined and endolined it with a Supera with a very, very good results distally, and that stood the, it's been there, it's been working for the last almost two and a half years. Superas have also been used across the AV fistulas in the arm.

We've just had experience of placing them on two occasions, and they seem to be doing fairly well. But the actual challenge that we actually, which we are up against is in the subclavian and in the iliac areas where the stents have to withstand the pulsatility,

the external compressive forces of calcium, and the bending fatigue. No single stent is ideal in all these indications. And the external iliac stents are more prone to fractures up to almost 5% as has been reported, and so there's a real need for a flexible, compliant,

self-expanding stent with a very high radial resistive force. In the subclavian arteries you can see if we place, for an ostial lesion we placed a balloon expandable stent. It tends to occlude at the level of the angulation, at the angulation, and we've endolined that

with a Supera coming up the arm with a very, very good result. As you can see, there's another stent which we've placed in the axillary artery, which is actually also held out. Now this is actually the area of interest. We've done almost about 25 such cases in the iliac artery.

You can see that the iliac has multiple turns and tortuosities and these actually is what results in all the fractures. And so this was a study which was done in the Acta Biomaterialia which was reported in July 2018 when they studied the extension, inflation, and torsion

for all these arteries and showed that there was a distinctly stiffer behavior in the circumferential than in axial direction of both the arteries, and the stiffness increased with age, especially in the iliac arteries.

So here's a patient who had actually a fractured stent, which was successfully endolined with a Supera coming up from the brachial root, and that encouraged us to actually use these for the aortoiliac occlusive disease. We came down from the brachial transbrachial approach,

both the right and the left side, and endolined them with Superas after placing aortoiliac self-expanding stents at the ostium and that is the final completion angiogram and there's another case in which this complete, almost near total occlusion,

and we managed to reline these with Superas and two aortoliliac stents beyond the, I mean, at the aortic bifurcation. So there's one Supera and one self-expanding stent on each side which actually gave us very good results. So this is exactly what our experience has been

for the last almost three years. We've done about 35 cases, 25 of them being in the aortoiliac segment. And of course, there's followup. And I must, there've been no fractures to date, and all the arteries,

all the stents placed have been patent. Obviously we looking at experience of other centers and of course long-term followup is something that really needs to be looked at. So thank you very much for the privilege of the podium. After placing aortoiliac

self-expanding stents at the ostium. And that is the final completion angiogram, and there's another case in which there's complete almost near total occlusion and we managed to reline these with Superas and two aortoiliac stents beyond the, I mean, at the aortic bifurcation.

So there's one Supera and one self-expanding stent on each side which actually gave us very good results. So this is exactly what our experience has been for the last almost three years. We've done about 35 cases, 25 of them being in the aortoiliac segment.

And of course there's followup, and there have been no fractures to date, and all the arteries, all the stents placed have been patent. Obviously we looking at experience of other centers, and of course long-term followup

is something that really needs to be looked at. So thank you very much for the privilege of the podium.

- Pleasure to be here again this year, discussing now something very exciting that we're going to be a part of at Baylor. Some disclosures, of which probably the fact that I educate and train for Boston may be relevant to this topic. Quick picture showing some of my own patients

that had chronic limb threatening ischemia over a year ago and just recently we had to do an angio again for some more proximal disease. And obviously not a surprise but at one year after drug alluding stenting, obviously balloon expandable stenting, the patency, actually it was more than that,

13, 14 months, it was fantastically open. On another terrible case, I had a patient that had a failed distal bypass and that one area of occlusion was the area where the bypass was amassed the most. Unfortunately after atherectomy, after balloon angioplasty

there was still acute recoil and I had to stent that area. I had to take the patient back a few months later for assisted primary patency and that stent had just become a mesh of useless metal and that's because that mobility at that proportion of the tibials is a lot.

So there's a lot to be said about the utilization of a non crushable scaffold in this segment. Tibial disease as is no secret to any of us is very diffuse, specifically in diabetics. And can be seen in a multitude of studies that there is an advantage of a scaffold

that has biological effect. Now granted most of these lesions have been very small and very short because of the availability of the structures and also because of what we've learned about the anatomy of the tibial and the areas of the tibials we've learned that not every single

part of the tibial vessels are actually amenable to a balloon expandable scaffold. Drug coated balloons have tried to expand the indication with some variable results as you look at the entirety of the studies out there. Now looking at what the patency has shown,

restenosis and freedom from TLR, it's been very obvious that those cases that have been scaffolded at 12 months have actually done very good, obviously the criticism and the constraint has always been lesion length. Smaller lesions have responded really well.

Now what would happen after that first year, we know from the PADI stud at 5 years is that when compared to PTA and bare meta stenting there is a very clear advantage that is maintained up to five years by using biological affects. So the SAVAL pivotal trial is a global pivotal trial

of a drug eluting system called the SAVAL stent. It's the first time that the differentiated technology selected for expedited access pathway has been awarded by the FDA and the anticipated enrollment us going to be Q3 2018, the idea of this flexible Nitinol self expanding stent is that it's going to be

compliant to most of the anatomy of the tibials. This is a polymer drug coating based scaffold. Somewhat in accordance or at least the same one that has been used previously for the Aluvia, that has been recently approved. This study is randomized, comparing DES below the knee

to percutaneous angioplasty alone below the knee. Doctor Mustapha is the global PI and Patrick Geraghty, Hans Overhagen and Masato Nakamura are going to be the co PIs for the global perspective as it will be conducted in Japan, in EU and in the United States.

There will be a perspective phase for this, so a two to one study with a limited size of 80 millimeter in length scaffold and then a phase B where they will allow us to put more than one scaffold, allowing longer lesions to be treated.

The objective is to get 200 patients, randomize again to two to one in 50 centers and we're looking for obviously CLTI patients Rutherford's class four and five, greater than 70 percent stenosis. Reference vessel diameter is going to be two five to

three 75 and total target lesion length is going to be initially less than 70 for coverage with one scaffold and then after that it's going to be freed up to hopefully less than 140 lesions. Primary patency at six months, it's going to be a superiority versus the PTA branch.

Certainly a major adverse events are going to be defined by above the ankle amputation, major reintervention and mortality. So the key features, primary patency measured at one, six, 12, 24 and 36 months. TLRs are going to be also seen.

Hemodynamic outcomes will be managed and assessed. Wound assessment will be also closely followed. Major amputation rate, Rutherford classification, quality of life and hospital readmissions. So in conclusions CLTIs associated with high amputation rates and poor clinical outcomes.

CLTI is commonly associated with below the knee lesions and challenging anatomy. Endovascular treatment has potential to increase wound healing and reduce amputation rates and the SAVAL clinical study will investigate safety and efficacy of a self expanding

drug eluting stent design particularly for the below the knee vessels, thank you very much.

- Thank you and good afternoon, everyone. These are my disclosures. So the characteristics of an ideal DCB. It must deliver the drug to the arterial wall during inflation, must distribute evenly within intima and media in the first few days,

and the therapeutic drug levels must be maintained for at least 28 days. The biological effects must be observed by histology at 28 days in animal models, and non-target effects should be minimum. So if you look at the Drug-Coated Balloon Devices

for the periphery there are a large number, those in the red show you the ones that have FDA approval, most of them have two or three, most of them actually, 2.0 micrograms per millimeter square of paclitaxel, whereas the other two that is Impact has 2.5 and Passeo has 3.0,

and of course, thaek-thee-piants are quite different. So here's to show you the SurVeil DCB which is a Surmodics balloon, this is showing you the coating on it, as compared to DCB #1, #2 and #3 that are already available in the market, at least in the United States,

and SurVeil is undergoing clinical trials. So what does it have? It has a 0.035 over the wire PTA platform, it has 4-7 millimeters, 40-150 millimeters in length, it has proprietary PhotoLink basecoat, and it has uniform drug topcoat,

consisting of paclitaxel and proprietary excipient which is 2.0 microgram of the drug, per millimeter square load, and it's 360 degree coating coverage, as you can see quite uniform coating, which makes it quite different from the others.

If you look at the Efficient Drug Delivery, you can look at tissue concentration, if you look at the Surmodics SurVeil, you can see that it has higher drug concentration up to 28 days, as compared to the bench DCB #2 which is 3.5 micrograms per millimeter squared.

So despite loading less drug, it has more drug in tissues. So what about the uniformity in distribution of the drug? The biological effects, these are the approved DCB, you can see that as focal effect the green showing the proteoglycan. If you look at the SurVeil DCB,

you can see that it has much more circumferential, and this is the plain old balloon. Not only that, but if you look at the biological markers of the drug effect, this is Surmodics, Benchmark DCB, which is 3.5 microgram,

I want you to note that if you look at the medial proteoglycan again, I showed you earlier here you can see it's much more so as compared to high loaded drug that is DCB which has 3.5. If you look at medial smooth muscle cell loss, much greater, that is in depth, as well as

in circumference, and if you look at endothelial loss, greater medial in Intimal Fibrin is greater and medial in intimal inflammations slightly greater. Therefore, is likely to have long-term effects. Now, looking at visible differences in the coating integrity, that is

it is submerge and deploy testing, you can see here in the Benchmark DCB #1, DCB #3 and SurVeil. You can look at this particulate material very easily, as compared to when you look at the SurVeil, we just don't see any particulates.

So visible difference in particulates released upon inflation. So we also did tracking and deployed particulate matter, that is simulated device use, prepare the balloon, track through the guide catheter in an anatomical model, inflate at 14 atm,

dwell time for 30 seconds, deflate, withdraw the balloon from the model and flush the model to recover the particulates, and the measurements are particulate count, drug retained in the balloon, and drug recovered from the mock vessel.

This is just to show you what you see as a particulate, you can see this is Surmodics, this is Benchmark #2, this is DCB #1, you can see the differences, I don't have to tell you, you can see the differences. This is 1 millimeter in size, some particles being close to 1 millimeter,

and greater, as you can see on the benchmark, as compared to what we see in the Surmodics. So if you look at the downstream effects in Glutius Maximum, Gastrocnemius, you can see that in SurVeil, you can see in Surmodics we see much less concentration of the drug

as compared to what we see in the DCB #2 which is 3.5 micrograms, and if you look at the coronary bands, minimal amount of paclitaxel seen in the concentrations. So in conclusion, currently available DCBs have downstream emboli in preclinical models that I showed you,

SurVeil DCB with advanced coating technology and a lower drug dose is able to achieve effective drug transfer into the arterial wall more circumferential, while minimizing downstream embolic effects in preclinical models. So thank you so much.

- There's a new DCB now on the market just C-marked, and I would like to share you interim data of this brand new Kanshas DCB into the preliminary data so far available. So, as we just heard, DCB is a wide-spread accepted technology, which delivers a durable anti-restenotic efficacy

after single-balloon inflation. I think this is clear, but definitely, as we have just seen from Dr. Vermani, efficacy is not a class effect. It is critical determined by the presence and choice of the excipient of each balloon.

And we know that from different studies like here, from Jopa, we can see that outcome efficacy is different in terms of the different effects of the DCBs. So this new and novel Kanshas Drug-Coated Balloon is covered with a paclitaxel 3.2 micrograms per square millimiter.

There's a unicoat technology, which is a uniform coating with micro-crystal aspects where the Paclitaxel is embedded with micro-crystal, which provides a large surface area, which facilitates a drug transfer to the lesion. It's available up to 200 millimeter.

It is a monorail balloon. You can see that in (mumbles) and some preclinical animal models, the Paclitaxel tissue concentration was definitely different in comparison to other already-established DCB, and of course, this new concept has now

to prove an efficacy and safety in the first human study. So, I can provide you now the six-months primary outcome of that KANSHAS 1 study on behalf of all the investigators. 50 patients were enrolled at six sites in Germany and Belgium. Patients will be followed up up to year, two years.

The primary endpoint is freedom from composite safety at six months. You see all the centers which enrolled patients between April 2017 and January 2018. Main inclusion criteria, Rutherford Clinical Category two to four,

lesion length up to 15 centimeter. Just want to highlight that also popliteal artery segments, could, when moved into study, I will show you also the outcome for the to P3 segment where we planted the balloon. The other baseline and lesion characteristic of the patient.

Typical risk profile, most of the patient had a Rutherford category three. On right side, you see the lesion locations, where the balloon was implanted. I see that 19 patients had a treatment with an popliteal artery.

Cumulative lesion length, 88.6 millimeter. As usual (mumbles) DSB trials classification was more on the lower side. Here the procedural characteristics. DCB per lesion 1.2. Total inflated length 72.1.

(mumbles) 14% of 14 patient, 28%, a little bit more on the higher side for that lesion length. This was due to flow limiting that section and residual stenosis. Here are the six-months outcomes in terms of hemodynamic outcomes

and Rutherford class change from a baseline. As you can see, most of the patients improved during this first six months of followup. Here's the freedom from composite safety and efficacy endpoint within couple of micro curve analyzed. This is a target of 100%,

which means freedom from device and procedure-related deaths through 30 days and freedom from target limb amputation and clinical driven TLR through six months. There were no device and procedure-related Severe (mumbles) during that six months of followup.

So let me conclude the DCB angioplasty for de novo femoropopliteal artery lesions with that new KANSHAS balloon was so far safe and efficient through six months of the procedure. It has a remarkable clinical hemodynamic improvement

at six months, but we have to wait, of course, the further followup 12 and 24 month. Thank you very much.

- [Audience] Is this DTB available in the US yet? - [Presenter] No, no, no. It's not available. - [Audience] Any idea of the timing? - This is first in human trial, so we just gained CE mark. I think it will take a couple years. - Less. Hopefully less than 2 years. It will take 2 years at least, I think. You're right.

- [Audience] Can I ask Dr. Virmani, we're starting to see the development of aneurysms following Paclitaxel delivery, so did we ought to be developing new devices that deliver increasing effects on collagen and smooth muscle cells, and did we ought to be docking at different drugs? - I think Paclitaxel is a cytotoxic drug, and we must all

realize we cannot get away with a large amount of drug. And you putting large amounts of this drug on a drug-coated balloon, even if you say only 20% goes in the artery wall, it's still a large amount of drug. And what we learned from the coronary arteries, we learned that it is toxic to the arterial wall. You get a lot of

fibrin deposition and also inflammation necrosis. The most important thing you get necrosis. So therefore, it does not surprise me that you're getting aneurysms in some cases. So, it's really not surprising. It would surprise me if you told me you had zero aneurysms. But yes we should be looking for new drugs. This is not

the drug ultimately that we should be using. - I have a following question for Dr. Virmani. So, you showed in the pre-clinical data that you had great drug penetration into the arterial media with a new DCB. So we saw a presentation in the last session of a device that actually injects the drug with a needle into the media

and the adventitia. So, what's the-you know you showed in sort of healthy arteries what the penetration is, how does it look in an unhealthy artery? Do we know, and do we need devices to actually inject the drug? - I'm not convinced that it is the only way to go. It depends on the diffusion capacity of the drug.

So, if the drug is effective like Paclitaxel for example, or most of the Serono MS group of drugs, or corticosteroid as they have done, I think it is a smart way of delivering as long as it circumferential and it goes up and down all the way. This is one of the things that is the limiting factor, that how much of the drug is going

circumferentially, how much is going from top to bottom, proximal all the way to distal? So, those things, and same way with balloons. I mean, it's a problem with balloons. To say all balloons are equal, I don't believe so. And I think it was nicely presented that all balloons are not created equal.

It depends on the distribution of the drug. How was the uptake? Unfortunately, we can't measure each quarter and say how much is the drug uptake in these. So, I think there are limitations both ways. - Dr. Parakh, I have a couple questions first for you, the Supera that you used were used in the

external iliac artery. In this country, the biggest Supera that we have is a 6.5, which has an outer lumen, an outer diameter of roughly 6.72, and an inner diameter of 6.0, which in most men would be smaller than the typical size that we would choose. Do you have a larger stent available in India?

- Yeah, we do with the 7 millimeter Supera. So, that is one. And the other is that, you know the arteries in the Indian patients, they are much smaller than the European or the American patients. - So, Western patients, so- - So the size of the arteries themselves, I think, in iliac,

in India in an average Indian male would not be more than eight or nine. So, I mean, putting in a seven there in a completely or nearly occluded artery is just about good. And you know there is a lot of calcium, if you stretch them too much then there's a chance of rupture as well.

So, if you can put them in, and they stay open, and you get a good inflow and an outflow, I guess that- - Interesting. And for the variant investigators in the two presentations here, one thing I didn't see was a breakdown in terms of sex, outcome, you know, differences in terms of the various sexes. Did you see any difference

between men and women at all, or were the results pretty consistent? - Yeah, we did the analysis and the outcome was the same for men and women. - It was the same? - Yeah.

- Yeah, and interestingly, the MIMICS-2 study was done as part of the harmonization by doing program with the FDA so we included a subgroup of Japanese patients, and the outcomes were the same in Japanese patients, and the outcomes were the same in the smaller superficial femoral arteries as well.

- That's very interesting. - Yeah. - That the small vessels I would think, would potentially have the greatest benefit from the swirling effect, you know, in looking at this. That's why I was asking about women. And Miguel, just for you, as you were

presenting the Sevalle proposal in terms of trial, we're going to be involved in that as well, it's certainly an exciting thing to perhaps be able to place distal stents without worrying about external compression, about these other things because it's a self-expanding stent. The stent that you showed was

compressed, was that a balloon expandable that had gotten destroyed distally? - Correct. - It was. - This is a bailout situation where I need to put a scaffold and the balloon-expandable scaffold I put in

obviously got completely crushed. - Yeah. - And I think all of us here have had that experience. Sometimes also the AT in the proximal segment can be tricky - Yeah - Certainly the distal third of all vessels, the peroneal

a little bit less maybe, but certainly the PT and the AT are very mobile in regard to the individual. - I agree. We've had those same problems. I can't wait to have another device in that area. Any questions from the audience? - You know, Dr. Walker, I wanted to ask Dr. Tapia

a question, because I find myself-and I know you probably have the most experience in drug-coated balloons, as we hear the data coming out for some good results in long lesions, more complex anatomy, but we still see that big number of 20 to 25% bailout stenting that get somehow written into the patency of the balloon itself.

My question to you is, I've never-even though I've asked for the data, they've never really told me how much scaffolding those bailout stents are. Is it focal, or is it point? So in your own practice, when you have a long CTO, maybe some calcification, how do you go about deciding, one-do you think it can

only be treated with a drug-coated balloon? Two, if you do need to scaffold as a bailout, how do you scaffold? End to end, or spot, or how-what is the thought behind that? - So, my general approach is to avoid scaffolding from the beginning. So, I do a very aggressive

pre- preparation of the diseased vessel, doing aggressive atherectomy balloon angioplasty, to do that as perfect as I can so that DCB is just a taxi to get the Paclitaxel- - Just to get the drug there. - Drug there-it's not a balloon, it's a taxi. So, therefore the preparation is in my view

the most important step, then I go with the DCB in, and if I see from a limiting dissection, I try to scaffold this with very short stent very focally, so no long stent implantation. Thomas Sellers said, "Don't harm your DCB resume with a bad stent implantation." So, I think this is quite

a valid citation. So, keep away from long scaffolding, use shorter stents we have a couple of devices available, very short ones. There are Tack System now coming up from Intact with very interesting two trial data, just focally heal the dissection. And if you're forced because of a severe recoil or massive calcification

still remaining, then you should go with a short stent, probably the Supera stent or the MIMIC stent where we have great data. - Can I ask a follow to that, to Dr. Virmani? Dr. Virmani, my understanding is that Paclitaxel is not taken up well into calcified arteries. So, how then

do you explain the good results? - If you produce cracks in the calcium, then you can actually get drugs into the calcium. Now, the problem really is, how far is it calcified? What we're noticing, and we're doing some work in the coronary, if the artery is calcified from lumen

to media, in that intima-media border in coronary arteries, if you look at the struts over it, they don't get to develop new intima that easily because they're not smooth muscle cells. They've got to come from somewhere else. So, really if you ask me, the calcified artery, heavy calcification, you're not going to do

anything there. What you're going to do is what's away from it, a vessel which you can dilate. So, that part of the vessel, which doesn't have calcium, is what is doing all your work. It is not the calcified artery. - Interesting. - So does that mean if you have extensive calcification

complete through lumen, circumferential.. - I would not put a stent. - Not put in a stent. What about a DCB? - I wouldn't put-DCB, tell me where is it going to go? First explain to me, how long is that lesion circumferential? Supposing it is greater than 5 centimeters,

in the case of periphery, you're not going to do any good to that patient. If he's got collaterals, let him live with it, if he can. If he can't, that's his bad luck. You're not going to make a difference, I will tell you this. If I have that, I wouldn't let you do anything to my life. - So a counter to that, though, is we're talking about

really calcified, thick, occluded vessels, chances are nine out of ten times, you're going to go sub-adventitial. - I beg your pardon? - Nine out of ten times, when you're crossing these very calcified CTOs, you're going to that sub-adventitial space. - Do you know CTO lesions actually don't have that much

calcification? What you have in peripheral arteries is medial calcification. - Correct. Still, technically speaking, you're going outside of the wall, correct, as you're crossing? - Not necessarily. You should, majority of the times you are, unfortunately, majority of the times you are.

- So, do you think that one layer that keeps the blood contained when we do a sub-adventitial or sub-intimal angioplasty, are there quiescent cells there that could get some sort of biological benefit by adding a drug-coated balloon? - Oh, absolutely. Absolutely. It will get you benefit.

Remember, it's not selective. The drug is non-selective. It kills everything. - But it's also the sub-intimal patients that Thomas Sellers says develop the most aneurysms. - Yes, absolutely, which makes sense. Which makes sense because what you've left is just the adventitia.

- And these aren't small aneurysms. Some of them are whoppers. - You wouldn't be surprised. It depends on how much drug you get there. - Are you more afraid of having even better balloons then? I mean, we're seeing aneurysms with version 1.0, you know,

do we need to push for the ultimate, perfect balloon that gives 100%, and are then going to make this worse with some massive aneurysms in the near future? - I don't have any evidence that I can tell you. But what I know is if I put a drug-eluting stent in that, we learn that we get aneurysms significantly.

- Significantly more. - Yes. - Because you get much more even distribution of the drug, you get higher concentration, and you get good necrosis wherever the strut is in touch with. (laughter)

- Good necrosis? - Yes. Necrosis is the worst thing you can do. You don't want necrosis. - That's why I was wondering why you called it "good necrosis". - No, I would not say "good necrosis".

Necrosis is never good. I would say we want a drug which is cytostatic not cytotoxic. That's the way we should think in the future. - Of course, that's how it's gone in the cholera, isn't it, with the lymus agents? - Yes. The reason lymus agents failed in the SFA-

why did they fail? Any one of you. - Because the drug wasn't taken up sufficiently, gives its lipo-because it's not lipophilic, they didn't last long enough. - I don't believe that's the reason. - They didn't last long enough for sure.

- I think one of the things was, if you look at the inter-strut distances, they were greater because in the early days, those stents had very high radial force. And now, you don't have high radial force, and therefore likely you will succeed if you put Serono MS group of drugs, more likely succeed than what you did at that time.

At that time, the radial force was far too great. In a animal, I can show you very effective at 90 days, but at one year, it's a disaster. I have 80% narrowing. Because my stent is three times the size it was originally. - It's always nice hearing from you, Dr. Virmani. - So with that, we have got to close out the session.

Our next sessions coming on. Thank you to all of you. This was a great session. - Thank you.

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