Boston Scientific has completed enrolment in the SuperNOVA trial, a global, single-arm, prospective, multicentre trial evaluating the long-term (12 month) safety and effectiveness of the Innova self-expanding stent system. This stent system is designed for treating patients with a narrowing or blockage of the arteries above the knee, often associated with peripheral arterial disease.
The study enrolled 299 patients at 51 sites in the USA, Canada, Japan and Europe and is expected to support regulatory submissions in the USA, Canada and Japan.
“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,” said Richard Powell, section chief, Department of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, USA, and professor of Surgery and Radiology at Geisel School of Medicine, and global principal investigator of the SuperNOVA trial. “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.”
The Innova Stent System consists of a nitinol self-expanding, bare metal stent loaded on an advanced 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 and a closed-cell design at each stent end for uniform deployment. The delivery system of the Innova Stent System features a tri-axial delivery catheter with an outer stabiliser sheath engineered to enhance deployment accuracy. The Innova stent is 6F compatible and available outside the US in diameters from 5mm to 8mm and lengths of 20mm to 200mm.
The Innova Stent System received CE mark approval in May 2012. In the USA, the device is investigational and not available for sale.