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Mark C. Bates, MD, FACC, FSCAI Professor of Medicine and Surgery

West Virginia University School of Medicine

ENDOVASCULAR INTERVENTION: UPDATE ON CURRENT TRENDS AND FUTURE

INNOVATIONS

•  Intellectual property / patents in past without current or future financial involvement

•  Boston Scientific

•  Abbott Vascular

•  W. L. Gore and Associates*

•  Founder, shareholder and/or active patents •  Nexeon MedSystems, Inc •  Presidio Medical, LLC

•  TAVIPro, LLC •  EngraftX, LLC*

•  Apollo Medical, LLC •  CeloNova BioSciences

•  AdaptX, LLC •  Consultant and shareholder

•  CeloNova BioSciences

•  Vascular Dynamics*

CONFLICT OF INTEREST

Financial Involvement No current financial involvement but inventor bias

*Will be discussed today

ROADMAP

•  What’s new? •  Hypertension devices •  Stent-grafts and covered stents •  New SFA alternatives •  In-situ stents and crosslinking •  Bioabsorbable stents •  Carotid disease changing

paradigms •  Cell therapy and angiogenesis

HOPE FOR RESISTANT HYPERTENSION?

Patient Impact:

Direct or indirect cause for 54 % of all strokes Direct or indirect cause for 47% of ischemic heart disease

1. Mathers C. et al., WHO 2009 2. 2003 WHO/ISH statement on management of hypertension 3. Lawes C.M. et al., Lancet 2008; 371: 1513 - 1518

Peet MM et al. Am J Surg 1948

Young female 3 years after toxemia of pregnancy with HAs, nausea and vomiting, blurred vision and

confined to bed

Splanchnicectomy Case reported in 1948 with 13 year follow-up

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Proven effective but fell out of favor due to surgical mortality and morbidity. In addition RX improved Mortality .5% but patients equipped with a special girdle with a superpubic spring pad for pressure. Some patients require aviator G-suit for severe orthostatic symptoms. 6 months recovery required before prolonged standing

RENAL NERVE ABLATION

Vessel Lumen

Media

Adventitia Renal Nerves

Renal Sympathetic Denervation

Symplicity® Catheter System, Ardian, Inc., Palo Alto, CA, USA

How it works RESULTS

RESULTS  SYMPLICITY  HTN  1  *   RESULTS  SYMPLICITY  HTN  2  *  

Symplicity HTN-2 Investigators, Lancet Published online November 17, 2010 DOI:10.1016/S0140-6736(10)62039-9

Simplicity 3 underway

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TODAY OVER 30 COMPANIES WORKING ON ABLATION SYSTEMS

Balloon driven RF Focused U/S Non-focused U/S Injection of neurotoxins External focused energy sources Multi-prong cage delivery systems Etc………..

WHAT ABOUT CAROTID-SINUS BASED SYSTEMS?

ONCE AGAIN --- WHAT WAS OLD IS NEW AGAIN

Carotid body stimulation

RESULTS OF CVRX

WHAT ABOUT AMPLIFIED PULSATILE ACTIVATION?

•  Facilitate baroreflex inhibition of SNA via central mechanisms (more effective)

•  Prevent “adaptation” or “resetting” •  Period of diastolic silence preserves the responsiveness

Am. J. Physiol. 271:H2218-H2227, 1996 CONFLICT

CHANGING CAROTID BULB STRAIN PATTERNS

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COVERED STENTS TO REDUCE RESTENOSIS? WHY LONG SFA STENTS FAIL

Stent distal edge

Stent distal edge

Confidential Information

SFA NITINOL STENT FRACTURE AND RESTENOSIS DUE TO AXIAL COMPRESSION AND STENT YIELD OR “HINGE POINTS”

Confidential Information

DRUG  ELUTING  BALLOON  SFA  ALTERNATIVE  NOTE:  REQUIRES    AN  EXCIPIENT  

•  Separates  Paclitaxel  molecules  

•  Balances    hydrophilic  and  lipophilic  proper<es  

•  Facilitates  Paclitaxel  elu<on  into  the  vessel  wall  

Paclitaxel  (3µg  /mm2  balloon  surface)  

Paclitaxel  +  Spacer  (excipient)  and  for  Medtronic  it  is  Urea  

BIOABSORBABLE STENTS SFA SOLUTION?

Problem: Fracture and differential absorption before engraftment

IN-SITU STENT

Crosslinking of proteins in the

extracellular matrix of the media and the collagen component

to the plaque

Target

CONFLICT

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FUTURE FOR SFA?

1.  Medical therapy with supervised walking that is covered by insurance and Medicare

2.  CCLI or true life-style limiting claudication •  Atherectomy followed by DEB?

•  DEB with provisional stent?

•  Bioabsorbable stent with designed fracture points?

•  In-situ stent via crosslinking? ARE WE UNDERESTIMATING THE VALUE OF

CONTEMPORARY MEDICAL RX IN ASYMPTOMATIC CAROTID DISEASE?

IMPROVED MEDICAL OUTCOMES IMPACT ON CAROTID TREATMENTS

Johnson ACAS Ipsilateral stroke

Control group

Contemporary results in control arms of

recent clinical trials

If ACAS was repeated today would the surgical arm meet

superiority over contemporary medical RX?

1.5% stroke in operated patients ACAS

Publication year

Ipsila

teral

Stro

ke (R

aw da

ta %

)

Ann L. Abbott. Stroke. published on-line Aug 20,2009

0

1

2

3

4

5

6

7

8

9

10

Past Present Future

Risk of stroke with CAS

Risk of Stroke with best medicaltherapy

THE RACE IS ON FOR ASYMPTOMATIC CAROTID DISEASE

Ris

k of

str

oke

%

When, if ever, will the lines cross?

HOWEVER CAROTID STENT AND SURGERY OUTCOMES ARE IMPROVING

Picture from the animal lab in

Charleston where the carotid flow reversal

model was developed

CONFLICT

PAEC

PEB

PBRS

Concept: Components:

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FIRST CASE OF FLOW REVERSAL ARGENTINA 1999 TODAY

Trial published this week with < 1% major stroke and 1.6% overall MAE

CHRONIC CRITICAL LIMB ISCHEMIA DOES CELL THERAPY REDUCE AMPUTATION?

CONFLICT

Autologous bone marrow stem cells: 79% limb salvage with non-healing wounds

Cell Transplant. 2010;19(11):1413-24. Epub 2010 Jun 7.

ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors) 1. O’Connell et al., based on the Massachusetts Male Aging Study on Impotence. Exp Gerontol. 2004 Jul;39(7):975-84

ERECTILE  DYSFUNCTION  CATHETER  BASED  TECHNOLOGIES  

•  FIM (ZEN trial) - Completed •  364 patients screened to

enroll 40 pts •  Close collaboration with

urologists and IC

Sustainable benefit but program abandoned by Medtronic

Robotic arm at patient table Remote physician console

The Magellan™ Robotic System

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THANKS