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FDA approves self-expanding stent system for PAD
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Boston Scientific announced that it has received FDA approval for a self-expanding stent system to treat narrowed or blocked superficial femoral or proximal popliteal arteries, according to a press release.
The company also initiated a simultaneous commercial launch of the Innova Vascular Self-Expanding Stent System (Boston Scientific) in the United States.
The system features a self-expanding, bare-metal nitinol stent, available in diameters of 5 mm to 8 mm and at lengths of 20 mm to 200 mm. The stent has open cells along the body and closed cells at both ends, designed to improve deployment, according to the release.
"The [superficial femoral artery] 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," Richard Powell, MD, section chief of the department of vascular surgery at Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, and principal investigator of the SuperNOVA trial of the Innova stent system, stated in the release.
SuperNOVA is an international, single-arm, prospective trial assessing the safety and efficacy of the system at 12 months in 299 patients enrolled at 51 sites throughout the United States, Canada, Europe and Japan. Enrollment for SuperNOVA was completed in August 2013, according to the company website.
The Innova Vascular Self-Expanding Stent System previously received a CE Mark in May 2012.
Disclosure: Powell reports consulting for Boston Scientific.