Stentys’ Next-Generation Self-Apposing Stent System Receives CE Marking

Stentys S.A. has received CE Marking for its new self-apposing stent system and officially has launched the device.

The company’s next-generation sirolimus-eluting self-apposing stent is dubbed Xposition S. It 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 company noted in a news release.

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.

“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,” said Gonzague Issenmann, CEO and co-founder of Stentys.

Stentys develops and commercializes solutions for the treatment of complex artery disease. Stentys’ self-apposing 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 infarctionshowed a very low one year mortality rate and a faster arterial healing compared to conventional stents. The company’s product portfolio also includes MiStent SES, a coronary DES whose new drug delivery mechanism is designed to match vessel response, and is marketed through the firm’s commercial network in Europe, the Middle East, Asia and Latin America.

The company is based in Paris, France, and operates a U.S. subsidiary in Princeton, N.J.