A Fixed Guidewire Stent Delivery System StentOnAWire Rationale

A Fixed Guidewire Stent Delivery System “Stent-On-A-Wire” Rationale, Design, and Development CRT Meetings Washington, D. C. February 23, 2010 Tim A. Fischell, M. D. FACC Professor of Medicine, Michigan State University Director of Cardiovascular Research Borgess Medical Center Kalamazoo, Michigan

Stent on a Wire (SOAW) Intoduction/Concept Ø Balloon on wire (e. g. , ACE) are very low profile. Ø Fixed wire balloons were viewed as a niche product because of risk of dissection without distal wire (no stent). Ø Fixed wire stent delivery system may have some real advantages and a broad range of potential applications.

Stent on a Wire (SOAW)

Rationale & Advantages: Stent on a Wire (SOAW) Ø Substantially lower crossing profile (40 -50% lower CSA) than monorail or OTW stent delivery. Ø More flexible and trackable to distal and tortuous anatomy (may be very important with DES). Ø Easily 5 Fr guide compatible (possible 4 Fr guide capability). Ideal for radial & outpatient stenting. Ø Ideally suited for crossing other stents and treating side-branches (through side cell of other stents). Ø Potential for major cost savings with direct stenting, no guidewire required; less contrast; no closure device; ? lower groin bleeding, etc.

Potential Cost Savings: Stent on a Wire (SOAW) Cost Savings Ø No need for coronary guidewire. $100 Ø Direct stenting with high pressure balloon avoids need for pre-dilatation balloon and most post-dilatation balloons. $300 Ø Reduced contrast use related to direct stenting and smaller guiding catheter, etc. $100 Ø 4 - 4. 5 Fr guide capability -> no need for closure devices and potentially fewer hematomas, transfusions, pseudoaneurysm & no closure device. $500 Ø May save 10 -15 min/case in cath lab time. $400 Ø Total potential savings/case - $1, 400

Effective Crossing CSA (mm 2) Comparative Profiles: Current Stents vs. SOAW

Comparative Profiles of OTW vs. SOAW 0. 0043” 0. 0029”

Comparative Profiles of OTW vs. SOW 0. 0043” 0. 0029” GUIDEWIRE LUMEN FIXED GUIDEWIRE

Comparative Profiles of Co. Cr Monorail vs. SOAW Vision Monorail (3. 0 mm SDS) Stent-on-wire (3. 0 mm SDS (Svelte))

Torque Control Using Prototype SOAW

Histopathology (Porcine Model) 90 Days Vision vs. Svelte Stents Vision 3. 0 mm Stent Svelte 3. 0 mm Stent

FIM Trial Direct Stent LAD (Rotterdam) Jan. , 2010 Pre-Stent Direct Stenting SOAW Final Result OCT

Anatomic Challenges in a DES World

Potential Applications: Stent on a Wire (SOAW) Ø Small and distal vessels. Tortuous vessels, particularly with Ca++. Direct stenting! Ø Radial and brachial artery stenting (4 -5 French). Ø Lesions that can not be crossed with conventional stent delivery system. Ø Sidebranches, for Y or T stenting through another stent. e. g. , kissing stents in 6 Fr. guiding catheter. Ø Workhorse for operators who want to use only 5 Fr (or even 4 Fr) guiding catheters; no closure required. Ø Outpatient stenting (It’s here!). Ø Cath labs that want to save $800 -$1, 400/case.

Updated Progress Stent on a Wire (SOAW) Ø Final stent design and SDS development completed; GLP animal testing completed with excellent results. Ø First in man trial started November 2009 (Dr. Patrick Serruys, Rotterdam). Ø U. S. clinical trial of bare metal (cobalt chromium) SOAW expected to start in mid 2010. Ø Expected CE Mark approval and sale in Europe in Q 2 2010. Ø Next generation coated (antithrombogenic) and novel ‘olimus DES versions are in preclinical testing.

Conclusions Stent-On-A-Wire (SOAW) Ø There a number of major, potential advantages to a stent-on-a-wire delivery system, compared to conventional monorail and OTW. Ø These stent delivery system will be much lower profile (~0. 029”) and more flexible, allowing delivery to distal and tortuous anatomy, and the use of very small diameter guiding catheters. Ø Potential cost savings, downsizing of sheath sizes (less bleeding) and improved outcomes with direct stenting may make this approach appealing for many operators.

Disclosures Ø Ø Co-inventor of stent-on-wire stent, licensed to Svelte, Inc. Co-founder of Svelte, Inc.

Comparative Profiles of Co. Cr Monorail vs. SOAW Stent-on-wire (2. 5 mm SDS) in 4 Fr. Diagnostic Catheter Vision Monorail (2. 5 mm SDS) in 6 Fr. Guiding Catheter