Stentys, a medical technology company commercialising the world's first and only Self-Apposing coronary stent, announced the first distribution agreements for its drug-eluting stent for treating BTK (Below-The Knee) arteries in Germany and Belgium, making it the first self-expanding drug-eluting stent commercialised for this indication in Europe.

The Stentys stent obtained CE Marking for the BTK indication at the end of 2015 following the excellent results achieved by the PES BTK-70 study, where it prevented amputation in 99 per cent of the 70 patients treated for Critical Limb Ischemia (CLI). The rapid launch of its commercialisation reflects a major medical need, particularly in Germany, Europe’s largest market.

Gonzague Issenmann, chief executive officer and co-founder of Stentys, commented, “We are delighted by the interest we received for our stent, the first in Europe to combine the benefits of self-expansion and drug-elution in the BTK indication. The peripheral artery disease market, currently estimated to be worth 1.3 billion dollars outside the United States and Japan and driven by the growing global prevalence of diabetes, represents a major growth driver for Stentys.”

The PES BTK-70 trial treated 70 patients suffering from critical limb ischemia of class 4 and 5 in the Rutherford scale with a Stentys Paclitaxel-eluting stent from January 2012 to May 2013 in five hospitals. The primary endpoint was the 12 month primary patency rate defined as absence of restenosis (=50 per cent) or occlusion within the originally treated lesion based on angiography verified by Core Lab. At 12 months, the primary patency rate was 73 per cent, freedom from target-lesion revascularization was 79 per cent and freedom from amputation was 99 per cent.