Boston Scientific's Innova peripheral stent débuts in Europe | Regulatory Roundup

May 15, 2012 by MassDevice staff

Boston Scientific, CE Mark in hand, says it plans to get its Innova peripheral vascular stent on the market immediately; also, Health Canada warns on metal-on-metal hip implants; U-Systems wins FDA approvable letter for breast ultrasound PMA; Maquet lands 510(k) for new aortic balloon catheter sizes; and more.

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Boston Scientific (NYSE:BSX) said it plans to get its Innova stent for peripheral artery disease on the market in the European Union "immediately" now that it's won CE Mark approval there.

The bare-metal Innova stent is designed to treat peripheral vascular disease, in which plaque builds up and partially occludes blood vessels in the legs. EuroZone regulators OK'd the device for treating lesions above the knee in the superficial femoral artery and proximal popliteal artery, according to a press release.

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"The company plans to launch the product immediately in Europe and other CE Mark countries," according to the release.

"The Innova stent is engineered to offer an advanced solution to treat blockages within these critical arteries," peripheral interventions president Jeff Mirviss said in prepared remarks. "This next-generation stent technology is designed to offer physicians improved acute performance and excellent long-term stent durability, intended to improve overall quality of life for patients with peripheral artery disease."

BSX said it's still enrolling patients in its SuperNova clinical trial, which is slated for up to 300 patients at 50 sites in the U.S., Canada and Europe. The company is running the trial under an investigational device exemption from the FDA and said it expects to complete enrollment during the 1st half of next year.

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