Image courtesy of Stentys
October 1, 2015 — Stentys announced that the company’s drug-eluting stent received CE Mark for treatment of below-the-knee (BTK) arteries. The approval makes it the first self-expanding and drug-eluting stent with regulatory approval in Europe for this indication.
The CE Mark was obtained following the results achieved by the device in the PES BTK-70 study in which the product prevented foot amputation in 99 percent of the 70 patients treated for critical limb ischemia (CLI).
The most severe cases of CLI, in which tissue of the foot or ankle does not receive a sufficient supply of oxygen and begins to die, often require amputation. To prevent this outcome, surgeons open up the artery with balloons and frequently implant stents. Approximately 25 percent of diabetics globally suffer from CLI and, according to the International Diabetes Foundation (IDF), the worldwide diabetic population is projected to increase from 387 million in 2014 to nearly 600 million individuals by 2035.
The PES BTK-70 trial treated 70 patients suffering from CLI 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 percent) or occlusion within the originally treated lesion based on angiography verified by Core Lab. At 12 months, the primary patency rate was 73 percent, freedom from target lesion revascularization was 79 percent and freedom from amputation was 99 percent.
For more information: www.stentys.com