PRINCETON, N.J. & PARIS--(STENTYS (FR0010949404 – STNT), a medical technology company commercializing the world's first and only self-apposing stent to treat acute myocardial infarction (AMI), announced today that one-year interim results from the APPOSITION III study will be presented during the Transcatheter Cardiovascular Therapeutics (TCT) conference, October 22-26, 2012 in Miami. Prof. Harald Mudra, M.D., Ph.D., of Klinikum Neuperlach (Munich, Germany) will present the results during the morning spotlight session “Primary PCI for STEMI: Drugs, Devices, and Technique Controversies” on Thursday, October 25, 2012 at 9:58 a.m.)--
“Better Stent Sizing Leads to Better Outcomes: The Self-Apposing Stent Technology”
STENTYS is also hosting a satellite symposium during TCT that will provide an overview of the STENTYS Self-Apposing® Stent clinical results to date and the proposed US IDE trial in STEMI. The symposium, chaired by Maurice Buchbinder, M.D., of the Foundation of Cardiovascular Medicine (San Diego), is being held Wednesday, October 24, 2012 from 12:15 p.m. to 1:15 p.m. at the Miami Beach Convention Center in Presentation Theater 2 and features presentations relating to the STENTYS Self-Apposing Stent by renowned cardiologists:
- Dr. Buchbinder will present “Better Stent Sizing Leads to Better Outcomes: The Self-Apposing Stent Technology”
- Prof. Mudra will present “Real-world Use in 1000 STEMI Patients: APPOSITION III One-Year Interim Results”
- Robert-Jan van Geuns, M.D., Ph.D., of Erasmus MC (Rotterdam, The Netherlands) will present “Routine Clinical Practice and Experience with a Self-Apposing Stent”
- Roxana Mehran, M.D., of Mount Sinai Hospital (New York) will present STENTYS’ proposed randomized IDE trial in STEMI, the APPOSITION V Study in the United States and Worldwide
Conference attendees who are interested in attending the symposium may register through the symposium webpage.
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. It fits into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase, thus reducing the risk of malapposition and complications associated with conventional stents in this setting.
About the APPOSITION III Study
APPOSITION III is a prospective, single-arm, multi-center (50 hospitals across Europe) post-market trial to assess the long term performance of the STENTYS Self-Apposing stent in routine clinical practice in 1,000 patients suffering from ST-Elevation Myocardial infarction (STEMI). The trial’s primary endpoint is Major Adverse Cardiac Events (MACE) at 12 months. MACE is defined as cardiac death, target vessel re-MI, emergent by-pass, or clinically-driven TVR by percutaneous or surgical methods at 12 months. The trial’s secondary endpoints are MACE at 30 days and 24 months post-procedure. The study completed enrollment in January 2012. The MACE rate at 30 days was 3.5% for the full study population and 2.5% when post-dilation was performed. Mortality rate at 30 days was 1.2% for the full study population.
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. The 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-month 30-day 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.
STENTYS is listed on Comp. C of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT