Boston Sci earns FDA approval of Innova stent to treat peripheral artery disease

Boston Scientific's FDA-approved Innova stent for PAD--Courtesy of Boston Scientific

Boston Scientific ($BSX) announced FDA approval of its Innova Vascular Self-Expanding Stent System for treating peripheral artery disease. The device was approved via the agency's stringent pathway for high-risk innovative devices.

Innova can be implanted in narrowed or blocked superficial femoral arteries of the thigh and proximal popliteal arteries of the knee. Innova consists of a bare-metal stent--which ranges in diameter from 5 mm to 8 mm and lengths of 20 mm to 200 mm--and a triaxial delivery system for predictable placement and uniform deployment, Boston Scientific says.

"The SFA and proximal popliteal arteries present a challenging environment for stents. The flexibility, radial strength and fracture resistance of the Innova Stent are designed specifically for this anatomy," said Dr. Richard Powell in a statement. He is chief of department of vascular surgery Dartmouth Hitchcock Medical Center in Lebanon, NH, and led the device's pivotal trial.

The 299-person trial commenced in August 2013 at 51 sites in the U.S., Canada, Japan and Europe, where Innova obtained a CE mark in 2012. The primary outcome was safety and vessel patency (or degree of openness) at 12 months, according to ClinicalTrials.Gov.

Boston Scientific says it is moving forward with a full commercial launch in the U.S. Interventional cardiologist Dr. Jaafer Golzar of Advocate Christ Medical Center in Oak Lawn, IL, was the first doctor to use the device commercially. He touted the device, saying, "The first step to achieving an optimal outcome is accurate placement, and then stent properties like radial strength and flexibility come into play," in a statement.

In 2011, the Innova was recalled from its U.S. trial and European countries because of reports of partial or no deployment. The FDA gave the recall its most severe, Class 1 designation.

Looking forward, Boston Scientific says the bare-metal Innova will be the platform for its drug-eluting Eluvia vascular stent, designed for the superficial femoral artery. The investigational Eluvia does not have FDA or CE mark approval.

Eluvia would compete with Cook Medical's Zilver PTX drug-eluting stent for PAD, which earned FDA approval in 2012.

Innova's approval adds to a crowded and ever-expanding field of devices to treat PAD.

Medtronic ($MDT) and C.R. Bard ($BCR) are having success with their drug-coated angioplasty balloons for the disease. The federal Centers for Medicaid and Medicare Services recognized the balloons innovative nature by granting them bonus reimbursement in inpatient and outpatient settings.

Boston Scientific sells drug-coated balloons for PAD and coronary conditions abroad. It is helping Bard distribute its Lutonix drug-coated balloon for PAD in the U.S.

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