Stentys Self-Apposing Stent Evaluated for CLI Treatment

January 28, 2015—Stentys announced that its Self-Apposing drug-eluting stent was evaluated in 70 patients with critical limb ischemia (CLI) and prevented foot amputation in 99% of these patients. Marc Bosiers, MD, principal investigator of the PES BTK-70 trial, presented the data at LINC 2015: the Leipzig Interventional Course in Leipzig, Germany.

The Stentys Self-Apposing stent is currently approved in Europe for a coronary indication. The company expects to receive CE Mark approval for a peripheral indication in the first half of 2015.

According to the company, the PES BTK-70 trial is a single-arm, prospective, multicenter clinical study initiated in 2012. The study enrolled 70 patients with severe foot wounds caused by CLI caused by a blockage in an artery below the knee (BTK). All patients in the PES BTK-70 study were treated with a Stentys paclitaxel-eluting Self-Apposing stent. At 12-month follow-up, 99% of patients did not require an amputation, with a 79% freedom from target lesion revascularization, and 73% primary patency under core lab-verified angiography.

Dr. Bosiers commented in the company’s press release, “Balloons alone have a limited efficacy for BTK lesions and we have yet to find the solution to treat these patients. This is the first time we are investigating a drug-eluting self-expanding stent in this setting and the results are extremely promising.” Dr. Bosiers is Head of the Department of Vascular Surgery at AZ St.Blasius Hospital in Dendermonde, Belgium.