Stentys Receives CE Mark for Self-Apposing Coronary Stent

Stentys has received CE mark approval for its Self-Apposing coronary stent for treatment of below-the-knee arteries.

The approval marks Stentys’ debut in the peripheral artery disease market, which is estimated at $1.3 billion outside the U.S. and Japan, the company says. It is also the first self-expanding and drug-eluting stent with regulatory approval in Europe for lower limb indications.

Stentys CEO Gonzague Issenmann says the company will look to formalize new distribution partnerships and begin marketing the product in 2016.

In a clinical study, the device prevented foot amputation in 99 percent of patients treated for critical limb ischemia. — Michael Cipriano