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September 27, 2015
Stentys' Self-Apposing Drug-Eluting Stent for BTK Approved in Europe
September 28, 2015—Stentys announced that the company’s self-expanding, self-apposing, paclitaxel-eluting stent (PES) received European CE Mark approval for treating below-the-knee (BTK) arteries. The company intends to formalize new distribution partnerships and expects to begin commercializing the device in 2016.
According to Stentys, the approval was supported by the device’s performance in the PES-BTK-70 study. The device prevented foot amputation in 99% of the 70 patients treated for Rutherford class 4 and 5 critical limb ischemia. Patients were treated at five hospitals from January 2012 to May 2013.
In PES-BTK-70, the primary endpoint was the 12-month primary patency rate defined as the absence of restenosis (≥ 50%) or occlusion within the originally treated lesion based on angiography verified by a core lab. At 12 months, the primary patency rate was 73%, freedom from target lesion revascularization was 79%, and freedom from amputation was 99%, reported Stentys.
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