PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--STENTYS (FR0010949404 – STNT), 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 balloon-expandable 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.
About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. Its flexible, self expanding design takes the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel, in particular after an AMI as the vessel dilates and the clot dissolves. It reduces the risk of malapposition and complications associated with conventional stents in this setting. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent should receive the CE Mark during the second half of 2014.
STENTYS is developing and commercializing innovative solutions for the treatment of patients with acute myocardial infarction (AMI, or heart attack) and complex coronary artery disease. STENTYS’ Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters, particularly in the post-infarction phase, in order to prevent the malapposition problems associated with conventional stents. In the APPOSITION III clinical trial, STENTYS stents demonstrated a very low one year mortality rate among 1,000 high-risk AMI patients when compared to recent studies with conventional stents. More information is available at www.stentys.com.
This press release contains forward looking statements about the Company’s business. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company’s products, market acceptance of the Company’s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, including with respect to a pre-market approval for the Company’s BMS, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 “Risk Factors” of the Company’s 2011 Registration Document (document de référence) filed with the French Autorité des Marchés Financiers on August 27, 2013 under number R.13-040 as such section may be updated from time to time.