1. A Novel “Stent-On-A-Wire”Ultra Low Profile Stent Delivery System
Update Svelte AcrobatTM Stent
CRT Meetings Washington, D.C.
March 1, 2011
Tim A. Fischell, M.D. FACC
Professor of Medicine, Michigan State University
Director of Cardiovascular Research
Borgess Medical Center
Kalamazoo, Michigan

2. Disclosures
Svelte Medical: co-founder, major shareholder, consultant, licensed patents.
Johnson & Johnson: licensed patents
Abbott Vascular: licensed patents

3. Stent on a Wire (SOAW)

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

5. Potential Cost Savings: Stent on a Wire (SOAW)
$100
$200
$400
$1,200
No need for coronary guidewire.
Direct stenting with high pressure balloon avoids need for pre-dilatation balloon and most post-dilatation balloons.
Reduced contrast use related to direct stenting and smaller guiding catheter, etc.
Fr guide capability -> no need for closure devices and potentially fewer hematomas, trans-fusions, pseudoaneurysm & no closure device.
May save min/case in cath lab time.
Total potential savings/case -

6. Comparative Crimped Profiles of Vision vs. SOAW

7. Torque Control Using Prototype SOAW

8. FIM Trial: Brief Trial Summary
N=44 patients; (P.W. Serruys (Rotterdam), Dr. Pieter Stella (Ultrecht), n = 18; Dr. Alex Abizaid, (Sao Paulo) n = 78; Dr. J Granada, Dr. A. Fernandez, (Envigado, Colombi) n = 9.)
Average Target Lesion Length (Visual Estimate): 12.9 mm
Mean Reference Vessel Diameter (Visual Estimate): 3.0 mm
SOAW Implanted: 44 (100%)
Direct Stented w/o Pre-dilation: 40/44 (91%)
Acute Results: MACE – CPK MB 3/44; No SAT.
30-day Follow-Up: SAT -0/44; TLR – 0/44; MI -1/44.

9. FIM Trial: Direct Stenting LAD

10. FIM Trial: Direct Stenting Subtotal Occlusion RCA

11. Mechanical Integrity Bioerodable-Biodegradable Sirolimus DES Coating

12. 30 Day Histopathology SOAW SES Bioerodable-Biodegradable Sirolimus DES Coating
SES SOAW
Bare Metal Co Cr

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

14. Updated Progress Stent on a Wire (SOAW)
FIM bare metal stent trial completed, with excellent results.
CE Mark approved and launched commercially in Europe (BMS) in Fall 2010, and Brazil in 2/11.
U.S. IDE for BMS Trial planned for mid 2011.
DES product manufactured, and completing pre-clinical evaluation with bioerodable/ biodegradable coating with promising results. FIM DES planned in 2011.

15. Stent-On-A-Wire (SOAW)
Conclusions
Stent-On-A-Wire (SOAW)
There are a number of major, potential advantages to a stent-on-a-wire delivery system, compared to conventional monorail and OTW.
This new stent delivery system is much lower profile (~0.029”) and more flexible, allowing delivery to distal and tortuous anatomy, and the use of very small diameter guiding catheters (4 French).
Potential cost savings, downsizing of sheath sizes (less bleeding) and improved outcomes with direct stenting may make this approach appealing for many operators.