Stentys SA (EPA:STNT) said yesterday it won CE Mark approval in the European Union for its drug-eluting stent for treatments of below-the-knee arteries.
The self-expanding, drug-eluting stent is the 1st of its kind with regulatory approval in Europe for BTK arteries, according to the French company.
“Entering the peripheral arterial disease market, which, outside of the U.S. and Japan, is estimated at $1.3 billion, represents a significant long term growth opportunity for Stentys. Now that the product is CE Marked, becoming the 1st stent that combines the benefits of self-expansion and drug-elution in this indication in Europe, we intend to formalize new distribution partnerships and expect to begin commercializing the product in 2016,” CEO Gonzague Issenmann said in prepared remarks.
The CE Mark was obtained based on results from the company’s PES BTK-70 study, which reported a 99% prevention rate of foot amputation in the 70 patients treated with the device for critical limb ischemia.
In April, Stentys said it won a CE Mark ahead of schedule for its self-apposing Xposition S coronary stent, a product that will be used with delivery system technology it acquired last June.
The early European regulatory O.K. enabled Stentys to officially launch its Xposition S system at the EuroPCR conference in May, the company said.