visit us at booth · continued on page 4 today’s highlights include: • morning industry...

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Continued on page 4 Today’s highlights include: Morning Industry Sessions start at 7:00 a.m. The ISET General Session continues at 8:00 a.m. in the Great Hall. • The Charles J. Tegtmeyer, M.D. Annual Lecture will be presented at 9:10 a.m. (See page 6.) • The ISET Exhibit Hall is open today from 9:00 a.m. to 3:30 p.m. Live case broadcasts take place at 9:30 a.m. and 1:50 p.m. (See page 3 for schedule.) Mid-day Industry Sessions start at 12:05 p.m. The Fellows Lunch Session starts at 12:15 p.m. in Regency Ballroom 1. Concurrent Sessions start at 4:30 p.m. The Fellows Reception starts at 6:00 p.m. Poster Session and Reception starts at 6:30 p.m. • Set your alarm: Tomorrow’s “How I Do It sessions start at 7:00 a.m. (See page 4.) ISET: Tuesday Continued on page 3 Tuesday, February 3, 2015 Issue 4 VISIT US AT BOOTH # 301 Y esterday’s ISET Town Hall, “The Future Is Now: A New Era of Innovation in Endovascular Medicine,” introduced the audience to futuristic tech- nologies and ingenuity. Each presenter shared exciting in- formation that raised the ques- tion, ‘What’s coming next in the endovascular arena?’ The potential for bioengi- neered blood vessels was in- troduced by Jeffrey Lawson, M.D., Ph.D. As he presented his data and research, Dr. Lawson explained that what he was about to impart was 15-plus years in the making. Looking first at synthetic conduits, he noted that one or two interventional proce- dures are required yearly to maintain a conduit’s patency. Thus, he has followed a path that has led him to the goal of bioengineering a blood vessel. Dr. Lawson pointed to a conversation with an anesthe- siologist that first launched the idea of creating a blood vessel. “We wanted to come up with a universal donor strat- egy, which takes advantage of organ donors,” he said, ex- plaining that they would har- vest the vascular muscle cells from the aorta, which requires decellularization to remove the host’s antigens. After investing 15 years in research, “We had to take a leap of faith and put it in a hu- man’s arm.” The first implant procedure occurred on De- cember 5, 2012, in Poland. He said the graft is still function- ing today. Six months later, the first implant procedure was per- Scaffolds, Conduits, Blood Vessels: Research Moves Forward T he future of renal dener- vation (RDN) is a picture without clarity. Four speakers on Monday showed cautious optimism that RDN reduces hypertension (HTN). But a year removed from the announcement by Medtronic that the Symplicity HTN-3 tri- al failed to meet its primary ef- ficacy endpoint, what happens next is unknown. Martin Leon, M.D., said Symplicity HTN-2 results spawned growth in the field. Then Medtronic made its an- nouncement a week prior to ISET 2014. It was a game- RDN: Still in the Hypertension Game? changer. Dr. Leon looked at three causes for the trial’s failed efficacy: • Operator and device is- sues: median cases per operator 2.6, so not a lot of experience. • Patient selection and drug prescriptions: identifying pa- tients with resistant hyperten- sion is difficult. • Study design factors: demographics of patient se- lection. “What’s the next step?” Dr. Leon asked. “How do we move forward if we believe this [RDN] has any future in treating our pa- tients with hypertension?” Dr. Leon pointed out that Symplicity HTN-3 did meet its safety endpoint. “It is a safe therapy,” he said. “Since there is confidence in RDN safety, we can transition to new stud- ies with earlier-stage hyper- tension patients. We need to treat RDN like any new hyper- tension therapy.” Two possible clinical trial designs were proposed by Dr. Leon: • Early Stage I/II HTN: wean to “off drugs” – placebo Dr. Barry Katzen moderates a live case presentation from Sao Paulo, Brazil on Monday. Dr. Sanjay Misra presents a case during SIR at ISET: The LEARN Approach to Critical Limb Ischemia (CLI), a new ISET session presented by the Society for Interventional Radiology (SIR). Session moderator Dr. Bret N. Wiechmann looks on.

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Page 1: VISIT US AT BOOTH · Continued on page 4 Today’s highlights include: • Morning Industry Sessions start at 7:00 a.m. • The ISET General Session continues at 8:00 a.m. in the

Continued on page 4

Today’s highlights include:• Morning Industry Sessions start at 7:00 a.m. • The ISET General Session continues at 8:00 a.m. in the Great Hall. • The Charles J. Tegtmeyer, M.D. Annual Lecture will be presented at 9:10 a.m. (See page 6.)• The ISET Exhibit Hall is open today from 9:00 a.m. to 3:30 p.m. • Live case broadcasts take place at 9:30 a.m. and 1:50 p.m. (See page 3 for schedule.)• Mid-day Industry Sessions start at 12:05 p.m. • The Fellows Lunch Session starts at 12:15 p.m. in Regency Ballroom 1. • Concurrent Sessions start at 4:30 p.m.• The Fellows Reception starts at 6:00 p.m.• Poster Session and Reception starts at 6:30 p.m.• Set your alarm: Tomorrow’s “How I Do It sessions start at 7:00 a.m. (See page 4.)

ISET: Tuesday

Continued on page 3

Tuesday, February 3, 2015Issue 4

VISIT US ATBOOTH #

3016701_ISET DAILY_Banner Ad_R1.indd 1 1/27/15 9:48 AM

Yesterday’s ISET Town Hall, “The Future Is Now: A New Era of

Innovation in Endovascular Medicine,” introduced the audience to futuristic tech-nologies and ingenuity. Each presenter shared exciting in-formation that raised the ques-tion, ‘What’s coming next in the endovascular arena?’

The potential for bioengi-neered blood vessels was in-troduced by Jeffrey Lawson, M.D., Ph.D. As he presented his data and research, Dr. Lawson explained that what he was about to impart was 15-plus years in the making.

Looking first at synthetic conduits, he noted that one or two interventional proce-dures are required yearly to maintain a conduit’s patency. Thus, he has followed a path that has led him to the goal of

bioengineering a blood vessel. Dr. Lawson pointed to a

conversation with an anesthe-siologist that first launched the idea of creating a blood vessel.

“We wanted to come up with a universal donor strat-egy, which takes advantage of organ donors,” he said, ex-plaining that they would har-vest the vascular muscle cells from the aorta, which requires decellularization to remove the host’s antigens.

After investing 15 years in research, “We had to take a leap of faith and put it in a hu-man’s arm.” The first implant procedure occurred on De-cember 5, 2012, in Poland. He said the graft is still function-ing today.

Six months later, the first implant procedure was per-

Scaffolds, Conduits, Blood Vessels: Research Moves Forward

The future of renal dener-vation (RDN) is a picture without clarity. Four

speakers on Monday showed cautious optimism that RDN reduces hypertension (HTN). But a year removed from the announcement by Medtronic that the Symplicity HTN-3 tri-al failed to meet its primary ef-ficacy endpoint, what happens next is unknown.

Martin Leon, M.D., said Symplicity HTN-2 results spawned growth in the field. Then Medtronic made its an-nouncement a week prior to ISET 2014. It was a game-

RDN: Still in the Hypertension Game?changer.

Dr. Leon looked at three causes for the trial’s failed efficacy:

• Operator and device is-sues: median cases per operator 2.6, so not a lot of experience.

• Patient selection and drug prescriptions: identifying pa-tients with resistant hyperten-sion is difficult.

• Study design factors: demographics of patient se-lection.

“What’s the next step?” Dr. Leon asked. “How do we move forward if we believe this [RDN] has any future in treating our pa-

tients with hypertension?”Dr. Leon pointed out that

Symplicity HTN-3 did meet its safety endpoint. “It is a safe therapy,” he said. “Since there is confidence in RDN safety, we can transition to new stud-ies with earlier-stage hyper-tension patients. We need to treat RDN like any new hyper-tension therapy.”

Two possible clinical trial designs were proposed by Dr. Leon:

• Early Stage I/II HTN: wean to “off drugs” – placebo

Dr. Barry Katzen moderates a live case presentation from Sao Paulo, Brazil on Monday.

Dr. Sanjay Misra presents a case during SIR at ISET: The LEARN Approach to Critical Limb Ischemia (CLI), a new ISET session presented by the Society for Interventional Radiology (SIR). Session moderator Dr. Bret N. Wiechmann looks on.

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HawkOne™

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CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.

COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. HawkOne is a trademark of a Covidien company. © 2015 Covidien. DA1788112014A

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3ISET Today: Tuesday, February 3, 2015

RDNContinued from page 1

Live Case Schedule: WednesdayWednesday AM:• Live from Leipzig, Germany: Patient with critical limb ischemia treated with tibiopedal puncture• 80 year old woman with left calf claudication and SFA disease

Wednesday PM:• 72 year old man with heel ulceration with SFA occlusion and tibial disease• 60 year old man with aortic to left renal artery bypass aneurysm• 53 year old man with h/o DVT and IVC filter penetrating into the IVC and duodenum presents for filter retrieval

See page 11 for Monday’s live case follow-up.

Live Case Schedule: TuesdayTuesday AM:• 83 year old man with enlarging 5.4 cm abdominal aortic aneurysm• 93 year old man with critical aortic stenosis and recurrent CHF and syncope

Tuesday PM:• 64 year old man with 5.2 cm abdominal aortic aneurysm with ulcerated neck• 68 year old man with bilateral popliteal artery aneurysms

vs. RDN; early 1 year endpoint deter-mination = proof of concept study.

• Poorly controlled HTN: “fixed” multi-drug regimen (? Standard poly-pill) – fixed drug Rx vs. +RDN = assess therapeutic effect.

Dr. Leon indicated the future could hold some promise for RDN, as two medical device manufacturers have clinical trials in development: Boston Scientific and Medtronic.

Boston Scientific has received Food and Drug Administration (FDA) ap-proval for the REDUCE-HTN: RE-INFORCE clinical trial, with the Ves-sixTM Renal Denervation System. “The trial should begin in approxi-mately one to three months. It will get us back on the right direction; we’ve lost a lot of momentum. We’ve learned it’s going to be a little more convoluted to get back on the path to use RDN to treat hypertension.”

Melvin Lobo, Ph.D., then offered the European perspective as to how the HTN-3 announcement trial impacted renal denervation that region.

“In Europe, we have seen a reduc-tion of RDN throughout Europe, par-ticularly in Germany, where insurance companies are reluctant to reimburse,” said Dr. Lobo.

He said the DENER-HTN trial has set the bar for future hypertension studies.

“I do believe RDN has a future,”

said Dr. Lobo. “But we need better markers of efficacy.”

Ron Waksman, M.D., echoed many of the same sentiments of Dr. Leon and Dr. Lobo.

“The enthusiasm that surrounded RDN in 2011, 2012 and 2013 has sub-sided,” he said.

Dr. Waksman also cited the com-plexity of the HTN-3 trial as a reason for its failure. He also noted that the good news from the HTN-3 trial was that RDN is safe.

Despite the HTN-3 news, Dr. Waks-man did indicate there is hope for RDN, under the following conditions:

• Identify the right target population;• Identify the target nerve for ablation;• Improve catheter design;• Receive immediate feedback that ablation was effective; and• Create the appropriate trial design.

“We do know that if you ablate more, you will get a blood pressure re-duction,” he said. “But how much do you need to ablate, and where do you ablate?”

Michael Jaff, D.O., wrapped up the day’s discussion of the topic with new opportunities for RDN, outside the field of hypertension. These included chronic kidney disease, diabetes and metabolic syndrome, atrial fibrillation, and obstructive sleep apnea.

Polling Results: Monday

Dr. Melvin Lobo

How would you treat a long SFA occlusion (>20 cm)?

How long do you leave balloon dilated during SFA angioplasty?

“Since there is confidence in RDN safety, we can

transition to new studies with earlier-stage

hypertension patients. We need to treat RDN like

any new hypertension therapy.”– Martin Leon, M.D.

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ISET Today: Tuesday, February 3, 20154

Town Hall Continued from page 1

Endoleaks: Regency Ballroom 1

Don’t Miss Tomorrow’s How I Do It SessionsCoffee service begin at 6:45 a.m. on Wednesday. Sessions start at 7:00 a.m.

Acute Limb Ischemia: Regency Ballroom 2

Dialysis Access: Regency Ballroom 3

Dr. Patel reviewed data from cell therapy trials conducted over the past 14 years that have addressed the is-sue of chronic heart failure. He also presented findings from the Utah OP-TIMIST Program, which included 15 clinical trials.

“The biology is defined and under-standable, but you need to take the tis-sue-engineered approach to truly have success,” he said. “We’ve only reached early part of success. The future of cell therapy is still very bright; small steps will lead to great progress in the future.”

Introduced as a leader in the field of biodegradability by ISET Course Di-rector Barry Katzen, M.D., Ron Waks-man, M.D., opened his presentation on the topic by identifying issues with permanent implants. These include:

• Chronic inflammation;• Caging the vessel;• Shear stress impairment; and• Stent fractures.“As we place metallic stents, we

have a compliance mismatch,” said Dr. Waksman.

He concluded by presenting a tri-fecta in coronary revascularization to show why biodegradable stents may change the landscape of coro-nary intervention: endoluminal by-pass (vs. conventional bypass), pre-venting PCI by sealing plaques, and a bioresorbable reservoir for specific indications.

Vickie Driver, DPM, brought cell therapy back to the table – focusing on what these therapies can offer for wound healing and reductions in am-putation rates.

“We need these therapies,” she said. “We need augmentations to what you do. We are still losing a lot of limbs and wounds still are not closing.”

Dr. Driver reviewed trial data from a phase 2 therapeutic angiogenesis NV1FGF trial (TALISMAN study). The primary endpoint was complete ulcer healing at 25 weeks, with amputation-free survival at 12 months being one of the secondary endpoints.

“Phase 2 was very successful; we

thought we had a winner,” she said. “Ulcer healing was not successful, but the secondary endpoint was very posi-tive.

Unfortunately, that’s where the good news ended. “In phase 3 (TAMA-RIS Study), it bombed dismally.”

As more trials are brought into the industry to advance cell therapy, Dr. Driver said one of the sticking points is the primary endpoint: “Is it wound healing or amputation-free survival? Time will tell.”

The session’s final speaker, Jordan Safirstein, M.D., discussed devices – but not medical devices for patients. He raised the question, “Is there a role for wearable computers in endovascu-lar therapy?

“Wearable computing is based on the concept that computing is not the primary task,” said Dr. Safirstein.

He identified three components of wearable computing:

• Consistency;• Multitasking; and• Augmented reality.As he looked at uses and applica-

tions for wearable technologies, such as Google Glass, education was at the top of his list. He showed how a wear-able device can allow procedures to be viewed off-site.

Other potential applications for wearable technologies include:

• Telemedicine;• Trauma (provides eyes in the field);• Pre-op checklists;• Cognitive disease assistance;• Medication compliance tools; and• Outpatient integration with EMR.Dr. Safirstein said wearable tech-

nologies can also be used to improve door-to-balloon times.

He did acknowledge that there are limitations to the technology, includ-ing privacy (HIPAA) and the depen-dence on wifi.

“Wearables able great and var-ied potential in medicine,” he said. “Google Glass is unfortunately not the answer, but we have interesting and excellent devices on the way.”

formed in the United States. To date, 60 bioengineered vessels have been implanted. Prevented from releasing more than limited data at this time, Dr. Lawson said there has been no evi-dence of immune recognition.

Dr. Lawson and his team then sought approval for arterial recon-struction, with the first procedure tak-ing place on October 11, 2013. To date, 20 femoropopliteal “fem-pop” bypass-es have been performed.

“After 15 years of research, we have

come to the end of the beginning,” said Dr. Lawson. “While we have made vascular conduits, our intention has been to make blood vessels available for everyone in every shape and size.

“The possibilities and engineering constraints are truly unlimited,” he said, adding that he anticipates it will be possible to bioengineer a heart in the next 50 years.

Amit N. Patel, M.D., presented the concept of novel human protein scaf-folds.

“We want to have a heart-specific scaffold that will not just regenerate, but provide strength and recruit other cells,” said Dr. Patel.

.

Dr. Jeffrey H. Lawson delivers the keynote lecture during Monday’s Town Hall.

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www.argonmedical.com

Presentations:

Visit Argon MedicalBooth 300-302

Introduction:

James F. Benenati, MD, FSIRProgram Director, ISETMedical Director of the Non Invasive Vascular LaboratoryFellowship Program DirectorClinical Associate Professor of Radiology, University of South Florida College of MedicineBaptist CaBaptist Cardiac and Vascular Institute

Designed by:

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ISET Today: Tuesday, February 3, 20156

STATE OF THE ART.

FROM THE FOUNDERS OF

VASCORE TRAINING& EDUCATION CENTERA DIVISION OF THE MGPO

VASCORETEC.ORG

Introducing the VasCore Training & Education

Center, a brand new concept for physicians,

technologists, corporate sponsors, and thought

leaders from around the world. We’re located in

the heart of Boston, a renowned technology and

innovation hub, on the campus of a leading

international health center.

Simply put, innovation is es-sential for moving forward good ideas.

In the annual Charles T. Tegt-meyer lecture, John Kaufman, M.D., MS, Director, Dotter Interventional Institute; Frederick S. Keller Profes-sor of Interventional Radiology, Or-egon Health & Science University Hospital, will bring home the no-tion that great ideas make for great change.

Dr. Kaufman’s lecture is titled “The Collision of Innovation with Contemporary Medical Mega-trends.” His presentation will be-gin today at 9:10 a.m.

“Innovation is essential not only to image-guided interventions, but all of medicine,” Dr. Kaufman said. “Without innovation, there will be little progress. Yet many of the ma-jor changes in medicine incentiv-ize innovation in process, such as delivery of health care, rather than treatment, such as new devices, procedures, and medications. Nev-ertheless, there are huge potential opportunities for innovation in

devices in personalized medicine, connectivity, and nanotechnology.

Dr. Kaufman is Professor of Di-agnostic Radiology, Surgery and Medicine at OHSU. A native of Boston, Dr. Kaufman worked at the Massachusetts General Hospi-tal from 1991 until 2000, when he joined the Dotter Institute. His re-search focus has been vena cava fil-ters and aortic stent grafts.

Dr. Kaufman has authored or co-authored more than 200 publi-cations, including five textbooks. He is co-editor of the quarterly re-view journal Techniques in Vascular and Interventional Radiology (TVIR), and is the section editor for Vascu-lar and Interventional Radiology for the American Journal of Radiology (AJR). He was honored as a Distin-guished Fellow of the Cardiovas-cular and Interventional Radiology Society of Europe.

Dr. Kaufman has served as Chair of the American Heart Association (AHA) Council on Cardiovascular and Interventional Radiology, Pres-ident of the Society of Intervention-al Radiology (SIR), and Chair of the SIR Foundation. He currently serves as a trustee of the American Board of Radiology.

Dr. Kaufman recently com-pleted a MS in Health Care Man-agement at the Harvard School of

Public Health. He is married to Cathy Kaufman, and they have three children, two grandsons, and four dogs.

Dr. Kaufman identified a few cru-cial moments on his journey.

“The first was when my wife Cathy agreed to our first date; she has made all of what I have done possible,” he said. “The other crucial moments are also related to people, those who have mentored and guided me in this specialty, including Alan Greenfield, Arthur Waltman, Stuart Geller, Anne Roberts, Matt Mauro, Gary Becker, Fred Keller, and Josef Rosch.”

The Tegtmeyer Lecture is partic-ularly special, he said.

“Charles ‘Tunk’ Tegtmeyer was one of the great interventional-ists, innovators, and mentors,” Dr. Kaufman said. “I was never lucky enough to meet or work with him, but his influence is present in what I do every day. I was extremely honored to be selected to give this talk, as Dr. [Barry] Katzen and his

group are, to a per-son, leaders in this field. I am hoping for a little glory by association!”

Dr. Kaufman said his many goals remain.

“I’m very excited about the changes in IR training that will be implement-ed over the next few years – a change from fellowship to residency – the mat-uration of focused

areas of clinical and procedural practice in IR, the incredible en-thusiasm and quality of the people coming into IR today, and a future in which collaboration across spe-cialties allows us to do more for our patients and further validates the value of image-guided interven-tions,” he said. “All that aside, I re-ally look forward to going to work each day.”

The collaboration with ISET has been special, he said.

“The Miami Baptist group has always been a leader in innovation and multidisciplinary collabora-tion,” Dr. Kaufman said. “I look forward to continuing to learn from them for a long time to come.”

Today’s Tegtmeyer Lecture: Making the Best Use of the Future

Follow ISET on Twitter:

@ISETNews

John Kaufman, M.D.

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NOW WITH5-YEAR DATA.1

Maintain superior 5-yearpatency through a provendrug effect.

1. Dake M. The Zilver PTX randomized trial of paclitaxel-eluting stents for femoropopliteal artery disease: 5-year results. Presented at: VIVA 2014: Vascular Interventional Advances Conference; November 4-7, 2014; Las Vegas, Nevada.

Caution: Federal (USA) law restricts the use of this device to sale by or on the order of a physician. Refer to the Instructions for Use for complete product information and full prescribing information including indications, contraindications, warnings, precautions and clinical data.

© COOK 01/2015 D16726-EN-F

www.cookmedical.com

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6701_ISET DAILY_SUPERA AD_R5out.indd 2 1/26/15 5:08 PM

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VISIT US ATBOOTH #

301

6701_ISET DAILY_SUPERA AD_R5out.indd 1 1/26/15 5:08 PM

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ISET Today: Tuesday, February 3, 201510

Exhibitor NewsExhibitor News features items submitted by companies advertising in ISET Today.

The content solely represents the views of the advertising company.

The all-new HawkOne™ device, the latest addition to Covidien’s directional atherectomy portfolio, recently received FDA 510(k) clear-ance. Just as the name implies, the HawkOne device allows physicians to treat all morphologies, including severe calcium, and offers procedur-al efficiency with enhanced cutting, crossing and cleaning capabilities.

Calcium is a prevalent real-world treatment challenge that is widely seen across many chronic conditions and is often linked to lower proce-dural success and reduced long-term outcomes. The technology enhance-ments of the HawkOne™ platform enable operators to treat these calci-fied lesions more effectively.

Crossing and cleaning enhance-ments streamline procedural ef-ficiency. The HawkOne device is a true 7 F platform, which crosses challenging lesions more predict-ably. The cleaning process has been simplified so there are fewer steps, saving valuable lab time.

Covidien’s HawkOne™ Directional Atherectomy System Receives FDA Clearance

“Covidien is committed to being the clear first choice for our physician and hospital partners by delivering new in-novative technologies that help save and improve patient lives,” said Brian Verrier, president, Peripheral Vascu-lar, Covidien. “The FDA clearance of the HawkOne™ system enhances our leading peripheral vascular portfolio and further demonstrates Covidien’s leadership in the atherectomy space.”

Covidien’s directional atherec-tomy portfolio includes the Turbo-Hawk™ and SilverHawk™ systems and is backed by more than 15 peer-reviewed studies, including the re-cently published data from the DE-FINITIVE LE study in the Journal of American College of Cardiology, Cardiovascular Interventions.

Covidien is a global health care leader that understands the chal-lenges faced by providers and their patients and works to address them with innovative medical technology solutions and patient care products.

Visit Covidien at booth 101B.

New Product Showcase

Argon Medical Devices, IncBooth 300-302

Argon Medical’s CLEANER XT™ and CLEANER 15™ Rota-tional Thrombectomy Systems are the only wall-contacting me-chanical thrombectomy devices with FDA clearance for mechani-cal declotting and controlled and selective infusion of physician-specified fluids, including throm-bolytics, in the peripheral vascula-ture. This new clearance enables physicians to apply CLEANER’s capability for cleaning wall-ad-herent thrombus to the peripheral vasculature when an IVC filter is present. The indication augments Cleaner’s existing clearance for mechanical declotting of native vessel dialysis fistulae and syn-thetic dialysis access grafts.

To learn more about these and other innovative products from Argon Medical Devices, visit Ar-gon Medical booth #300-302.

PAID LISTINGS

Hansen MedicalBooth 305

The Magellan Robotic System is used by physicians worldwide to navigate peripheral blood vessels in a wide variety of en-dovascular procedures. Magel-lan enables precise steering of guide wires and proprietary ro-botic catheters through complex anatomy, and provides a highly stable platform for the manual delivery of therapy. Physicians may also perform Magellan pro-cedures while seated at a re-mote physician console, away from radiation.

Most recently, Hansen intro-duced the Magellan 6Fr Robotic Catheter, which extends the ben-efits of robotic precision, stability and control to peripheral vascular procedures in smaller vessels.

When examining patients for possible peripheral artery disease (PAD), a thorough

review of exam results is key to mak-ing the most accurate diagnosis. At Sunday’s “Arterial Symposium on Noninvasive Vascular Diagnosis” pre-symposium, speakers addressed PAD and discussed detection of stenosis, as well as the benefits of stent surveil-lance, and how to avoid mistakes in diagnosis that could prove detrimental to patients.

On the topic of pulse volume record-ings (PVR) and Doppler waveforms, Laurence Needleman, M.D., compared stenosis to a filter, and explained how it affected blood flow.

“On a pressure waveform, pulse shape varies thru the circulation. Ste-nosis affects the blood flow beyond it in several ways and shows itself on the waveform. Doppler shows the site of the stenosis, and encourages an accu-rate assessment.”

Continuing the discussion, Michael Jaff, D.O., gave reasons for peripheral artery stent surveillance, and what benefits result from such monitoring.

“Why follow patients after stent

Optimizing Noninvasive Exam Results for Accurate Assessmentsplacing? Because early detection of in-stent stenosis may offer more alterna-tives for revascularization. When con-sidering stent surveillance, we must look at the cost, complexity, and risk. In peripheral artery stent surveillance, the optimal duplex ultrasound find-ing most suggestive of stent restenosis is peak systolic velocity (PSV) ratio, which can be assessed based on an ac-cepted numeric range.”

He added, “In peak systolic velocity, the normal range is 60-100 cm/sec and significant stenosis is considered great-er than 200 cm/sec; however, these numbers are not 100 percent reliable in all patients.”

Jeffrey Olin, D.O., pointed out that “Renal artery stenosis was developed primarily for atherosclerotic stenosis. Make sure you look at the renal to aor-tic ratio to fully see everything, and not miss anything for the most accurate patient diagnosis.”

Helping practitioners avoid the common mistakes that occur in ab-dominal Doppler exams, John Pelleri-to, M.D., listed the keys to successful assessments.

“The keys to successful abdominal

Doppler exam are patient preparation, adequate equipment, operator experi-ence, technique shortcuts (such as op-timize the Doppler image), optimal di-agnostic criteria, and correlation. The most common pitfall for mesenteric stenosis is a non-fasting state; howev-er, there are many other pitfalls as well that should be avoided.”

Wrapping up the session with the topic of arterial exam reports, Dr. Jaff returned to the stage, and encouraged physicians to be careful when describ-ing exam findings.

“When evaluating for PAD disease, remember the limitations, as with an-kle brachial index and segmental leg pressures. Also compare all prior ex-ams with current ones and look at the medical history of the patient to see if there are factors contributing to the suspicion of PAD. This is the best way to know your diagnosis is as accurate as it can be.”

When it comes to PAD and stenosis assessments, an accurate diagnosis is perhaps the best noninvasive consid-eration for both patient and physician.

Drs. Donald Garbett, left, and Pallav Shah, view posters on display in the exhibit hall. Abstract authors will be available to answer questions during tonight’s poster session and reception, 6:30 - 7:00 p.m.

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11ISET Today: Tuesday, February 3, 2015

72 year-old man presents with lifestyle limiting right calf claudication secondary to multi-segmental disease of the superficial femoral artery.Initial angiogram demonstrating high grade stenosis of the distal SFA (Fig 1). Following treatment with 6mm x 120mm IN.PACT Admiral (Medtronic) Drug-Coated Balloon, there is an excellent angiographic result (Fig 2). Stenotic lesion in the proximal SFA is seen on this subsequent angiogram (Fig 3). Post angioplasty of proximal lesion with Lutonix (Bard) 6mm X 40mm Drug-Coated Balloon demonstrates a widely patent vessel. Operators: Drs. James Benenati, Shaun Samuels, Jaime Wagner.

Monday Live Case Follow-Up 67 y/o man presented with lifestyle limiting right calf claudication beginning approximately 6 months ago and preprocedure imaging demonstrated a long segment SFA occlusion (Fig 1) as well as continued patency of a previously placed distal right SFA drug eluting stent (Fig 2). After the occluded segment was crossed, two 6mm x 100 mm and one 6mm x 80mm Zilver PTX drug eluting stents (Cook Medical) were placed and subsequently dilated to 5mm. There was also moderate in-stent stenosis in the previously placed distal SFA drug eluting stent which was treated with a 5 mm Charger balloon (Boston Scientific) followed by a 5mm x 100mm Lutonix drug eluting balloon (Bard). Final angiograms (Fig 3 and 4) demonstrated a recanalized right SFA without residual stenosis and brisk in-line flow to the foot.Operators: Drs. Alex Powell, James Benenati, Brian Schiro, Emerson Sharpe

63 y/o M with history of right ICA occlusion presented with watershed infarct in the right hemispheric white matter. During work-up for his right internal carotid artery (ICA) occlusion, a critical (80%) stenosis was also noted at the left internal carotid artery (Fig 1) as well as a 50% stenosis of the left common carotid artery (Fig 3). The patient was considered high-risk for CEA. He was treated with left ICA stenting (8 x 30 mm Precise stent (Cordis), dilated to 4.5 mm) with Accu-Net (Abbott) distal embolic protection with excellent angiographic result (Fig 2). Additionally, a 40 mm Hg pressure gradient was noted across the left CCA and intra-procedurally the sheath was occlusive. This was treated with a 7 x 27 mm Express stent (Boston Scientific) at the origin of the left CCA with patent vessel post treatment (Fig 4). Final angiogram demonstrated vigorous cerebral flow, with filling of the right middle and anterior cerebral arteries via the anterior communicating artery.

Operators: Drs. James Benenati, Guilherme Dabus, Timothy Yates

Fig. 1 Fig. 2

Fig. 3 Fig. 4

Fig. 1 Fig. 2 Fig. 3 Fig. 4

Fig. 1

Fig. 2

Fig. 3Fig. 4

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Advancing Lives and the Delivery of Health Care™

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Moderated by:

Dr. Barry KatzenMiami Cardiac & Vascular Institute

Presentations by:

Dr. Renu VirmaniCV Path Institute

Dr. Chris MetzgerWellmont CVA Heart Institute

Tues., Feb. 3, 201512:05-12:50 pm

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Discussion on Pre-Clinical Safety Studies, and Insights

from LEVANT 2 and the Global SFA Registry

Advancing Lives and the Delivery of Health Care™

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