Stentys this week said it won a CE Mark ahead of schedule for its latest self-apposing coronary stent, a product that will be used with delivery system technology it acquired last June.
The early European regulatory O.K. enables Stentys to officially launch its Xposition S system at the EuroPCR conference May 19, the company said.
"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," CEO and co-founder Gonzaque Isenmann said in prepared remarks.
The advance should allow for "much faster adoption" of the company’s self-apposing stent technology by interventional cardiologists, Isenmann added.
XPosition S is a next-generation sirolimus-eluting self-apposing stent delivered by a system that uses a small balloon to split open the sheath containing the stent. By doing so, the stent is released at the exact, intended location. Stentys said the system resembles conventional stent implanting processes, makes the delivery process easier and doesn’t require training.
Stentys said its delivery system for Xposition S is based on Cappella Peel Away technology it acquired in June 2014. The technology is cleared for the European market and has been used for Cappella’s Sideguard coronary bifurcation stent. As part of the deal, Cappella said it would keep the rights to the technology for Sideguard and for other potential applications.
In February, Stentys touted clinical trial data showing that its self-apposing drug-eluting stent has merit as a treatment for the booming peripheral artery disease market.
Stentys is based in Princeton, N.J., and Paris.