Self-Apposing® Coronary stent maker STENTYS, has received CE Mark approval for its new Xposition S™ system ahead of plan. This will allow the company to market the new products in Europe and in all the other countries where this certification is recognized.
Background
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex artery disease. STENTYS’ SelfApposing® drug-eluting stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. The APPOSITION clinical trials in the treatment of acute myocardial infarction showed a very low one year mortality rate and a faster arterial healing compared to conventional stents.
STENTYS’ next-generation sirolimus-eluting Self-Apposing stent, Xposition S™ is delivered by a unique and clinically proven stent delivery system that closely replicates conventional stent implantation techniques, making the implantation of a STENTYS stent easier and requiring practically no training. The delivery system was designed based on the Cappella Peel Away technology that the Company acquired less than a year ago: a small balloon splits open the sheath containing the stent to release it precisely at the intended location.
With its new CE mark, STENTYS says it will officially launch Xposition S™ at the EuroPCR conference on May 19, 2015.
Company comments
Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, stated: “This CE Marking represents a quantum leap in terms of product design as we now have a stent delivery system that mimics how a conventional stent is implanted, thereby paving the way to much faster adoption of the Self-Apposing technology by interventional cardiologists.”
Source: Stentys, Inc.
published: April 30, 2015 in: Approval/Clearance, Cardio, Launches / Withdrawals, News