Stentys, a medical technology company commercialising the Self-Apposing coronary stent, announced on 28 September 2015 that the company’s drug-eluting stent received the CE mark for treatment of below-the-knee (BTK) arteries, making Stentys’ product the first self-expanding and drug-eluting stent with regulatory approval in Europe for this indication.
According to Stentys, the CE mark was obtained following the strong results achieved by the company’s stent in the PES BTK-70 study in which the product prevented foot amputation in 99% of the 70 patients treated for critical limb ischaemia.
“Entering the peripheral arterial disease market, which, outside of the USA and Japan, is estimated at US$1.3 billion, represents a significant long-term growth opportunity for Stentys,” said Gonzague Issenmann, CEO and co-founder of Stentys. “Now that the product is CE-marked, becoming the first stent that combines the benefits of self-expansion and drug-elution in this indication in Europe, we intend to formalise new distribution partnerships and expect to begin commercialising the product in 2016.”
The PES BTK-70 trial treated 70 patients suffering from critical limb ischaemia 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%) or occlusion within the originally treated lesion based on angiography verified by core lab. At 12 months, the primary patency rate was 73%, freedom from target lesion revascularisation was 79% and freedom from amputation was 99%.