Medical device giant Boston Scientific’s (NYSE:BSX) enrolled the last of 299 patients in its SuperNOVA trial, moving the company 1 step closer to completing the clinical evaluation of its Innova bare metal stent.
The Innova self-expanding stent system is being used to treat patients with blocked arteries above the knee, a condition often associated with peripheral artery disease. The trial, which spans 51 centers around the world, is expected to provide clinical evidence to support Innova regulatory approval in the U.S., Canada and Japan.
SuperNOVA is a single-arm study, and all patients will be treated with Innova and monitored for positive and negative outcomes for 1 year after the procedure.
The Innova stent system already landed CE Mark approval, but is only available under investigational use in the U.S. According to Boston Scientific, the potential patient market extends to 27 million patients across the globe.
Innova is a self-expanding cylindrical tube that props open inside the blood vessel. The company touts a delivery catheter with 3 axles and a "stabilizer sheath" to help surgeons accurately place the stent.
Jeff Mirviss, president of peripheral interventions, said the company expects Innova "will provide physicians with a new alternative to treat peripheral artery disease in the challenging vascular environment above the knee," according to a press statement.