Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia.
The peripheral stent is the first of its kind to undergo the FDA’s breakthrough device program, according to the medtech giant.
Roughly 17 million people in the U.S. live with peripheral artery disease and 11% ultimately develop critical limb ischemia, Boston Scientific reported. Within one year of being diagnosed with critical limb ischemia, 30% of patients will have undergone amputation, the company added.
Treating arterial blockages below the knee can be difficult since vessels tend to recoil to maintain their original shape. Boston Scientific’s Saval stent system is designed to overcome this problem using a paclitaxel-polymer combination that slowly releases an anti-restenotic drug. The drug minimizes tissue re-growth and vessel recoil, according to Boston Scientific.
“Critical limb ischemia is a serious condition, affecting numerous patients at increasing rates across the globe,” Dr. Jihad Mustapha, global principal investigator of the Saval trial, said in prepared remarks. “The commencement of the Saval trial signals the advancement of endovascular techniques featuring the latest in drug-eluting stent technology, with the potential to drastically improve the quality of life for patients who live in fear of losing their legs due to CLI.”
The trial is slated to enroll 200 patients and compare the Saval stent to percutaneous transluminal angioplasty in patients with critical limb ischemia.
“In our pursuit to address unmet clinical needs, the Saval BTK Stent System is a proof point in our long-standing commitment to develop and invest in solutions that improve clinical outcomes, especially in tackling the unique challenges that critical limb ischemia presents,” Dr. Ian Meredith, EVP & global chief medical officer, added. “As a result of the FDA granting Boston Scientific a breakthrough device designation, we have the opportunity to accelerate our ability to provide clinicians with a comprehensive portfolio of drug-eluting therapies and rotational atherectomy technologies specifically designed for the treatment of peripheral vascular disease.”
