Enrollment Completed in SuperNOVA Trial of Boston Scientific's Innova System for SFA/PPA Treatment

August 19, 2013—Boston Scientific Corporation (Natick, MA) announced that it has completed enrollment in the SuperNOVA trial. The study enrolled 299 patients at 51 sites in the United States, Canada, Japan, and Europe.

SuperNOVA is a global, single-arm, prospective, multicenter trial evaluating the long-term (12-month) safety and effectiveness of Boston Scientific's Innova self-expanding stent system in the treatment of above-the-knee peripheral arterial disease. The SuperNOVA trial results are expected to support regulatory submissions in the United States, Canada, and Japan, advised the company.

According to Boston Scientific, the Innova stent system is designed specifically for use in the superficial femoral artery and the proximal popliteal artery. The device consists of a nitinol self-expanding, bare-metal stent loaded on a low-profile delivery system. The stent architecture features a uniform, open-cell structure along the stent body designed for enhanced flexibility, radial strength, and fracture resistance. A closed-cell design at each stent end is designed for uniform deployment. The Innova's delivery system features a triaxial delivery catheter with an outer stabilizer sheath engineered to enhance deployment accuracy.

The company stated that the Innova stent is 6-F compatible and available outside the United States in diameters from 5 mm to 8 mm and lengths of 20 mm to 200 mm. In Europe, the Innova stent system received CE Mark approval in May 2012. In the United States, the device is investigational and not available for sale.

The global principal investigator of the SuperNOVA trial, Richard Powell, MD, commented on the Innova device in Boston Scientific's press release. Dr. Powell is Section Chief, Department of Vascular Surgery, at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and Professor of Surgery and Radiology at Dartmouth's Geisel School of Medicine.

Dr. Powell stated, “Treating vascular lesions in the superficial femoral artery and proximal popliteal arteries is particularly challenging due to a variety of anatomical factors, including vessel length and tortuosity. From my experience in the clinical trial, the Innova stent system offered the design characteristics required for acute and long term success in these challenging vessels, including radial strength, flexibility, fracture resistance, and long stent lengths.”