Over 20 case presentations
3 clinical trials in “Hotline” Late Breaking sessions
2 dedicated symposia

PRINCETON, N.J. and PARIS - STENTYS, a medical technology company commercializing in Europe the world's first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), today reported on multiple sessions, symposia and case presentations featuring STENTYS stents during the annual EuroPCR meeting held in Paris last week.

· Late Breaking sessions: 3 Trials on STENTYS Technology

1. APPOSITION IV: Sirolimus-eluting stent shows excellent efficacy and faster healing

In the much anticipated final results from APPOSITION IV, the sirolimus-eluting Self-Apposing stent (SES) demonstrated excellent efficacy compared to market leading stents and faster healing compared to balloonexpandable stents. With these results, the STENTS SES could receive CE Mark as soon as the second half of this year.

2. ADEPT: Self-Apposing stents are well suited for treatment of diseased bypass grafts

Sander IJsselmuiden, M.D., Ph.D., of Albert Schweitzer Hospital in the Netherlands presented 6-month results of ADEPT, a prospective, multi-center, randomized, two arm clinical study that enrolled 40 patients treated for a diseased coronary artery bypass graft with either the STENTYS paclitaxel-eluting stent (PES) or the STENTYS bare metal stent (BMS). Treatment with STENTYS Self-Apposing stents in this setting was found safe and effective, with late lumen loss in line with previous STENTYS trials in native vessels. SVGs, a type of graft, can become diseased over time and have uncertain diameters due to the presence of clots and debris, thus increasing the risk of undersizing or oversizing with conventional balloon-expandable stents. STENTYS Self Apposing stents are designed to maintain continual apposition within the vessel; the treatment of bypass graft narrowing was added to the STENTYS CE certificate as an additional indication in 2013.

3. OPEN II: Data reinforce expanded use in indications beyond STEMI

Christoph K. Naber, M.D., Ph.D., of Contilia Heart and Vascular Center in Germany presented the 12-month results of the OPEN II study, which enrolled 217 patients with coronary bifurcation narrowing treated with the STENTYS PES, and a comparison at 9 months to the landmark BBC I trial. Despite a more severe population, the STENTYS PES performed equally well with a MACE rate of 12.6% vs 11.2% (p=0.63). Bifurcations, which are also part of the CE certificate indications, account for 15% to 20% of all coronary lesions treated by percutaneous coronary intervention (PCI).

· Over 20 patient cases presented throughout the conference

The EuroPCR organizers encourage cardiologists to share clinical experience with their peers by way of patient case studies presented during the congress. More than 20 patient cases featuring a STENTYS stent were presented during the course of the week. The technology was often highlighted as a valuable option to address shortcomings of conventional stents.

“I was very impressed to see how my European colleagues have incorporated the STENTYS stent as an integral part of their treatment armamentarium,” commented Roxana Mehran, M.D., of Mount Sinai in New York and a member of STENTYS’ Scientific Advisory Board.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, said: “This year’s EuroPCR, one of the leading congresses in interventional cardiology, has been our most successful to date. The data presented continue to highlight the strength of STENTYS Self-Apposing stents in a variety of clinical settings, and the frequent, spontaneous mention of our stent in peer debates is a clear sign that it is becoming an indispensable tool in today’s cath lab.”

· Upcoming event
STENTYS is participating in French Life Sciences Days, on June 25-26, 2014 in New York.

Source: STENTYS