Exciting news for patients with peripheral arterial disease (PAD) and the physicians who treat them: No more using off-label expandable stents now that an the first stent to receive FDA approval to treat narrowed iliac arteries is now available to patients.
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Stents work like struts, propping up collapsed arteries. They are inserted during a procedure called angioplasty using imaging and a balloon catheter. The process is a minimally invasive way to restore a patients blood flow.
This new stent showed promise during the ACTIVE trial, which included 123 participants who received the stent. Only one of the patients in the trial required a reintervention during the 9-month follow-up. What’s more, the stent performed at keeping blood vessels open,called patency rate, earning a 99.2 percent rating.
Fortunately, the endovascular field is moving toward more evidence-based trials where devices have appropriate indication for what they are actually being used for,” says Mehdi Shishehbor, D.O., Director, Endovascular Services, Cleveland Clinic.
The stent is comprised of a unique mechanical makeup; cobalt chromium and a modular design. This offers patients an ultra-thin, round, edgeless stent that conforms to the artery wall, which also eases implantation for physicians.
“In the last two decades, the endovascular community has used ‘off-label’ balloon-expandable stents for iliac arteries, this approval allows us to use an FDA indicated device to treat patients.” Dr. Sishehbor says.