Boston Scientific Launches Stent System in Europe

Boston Scientific has received CE Mark approval in for its Innova self-expanding bare-metal stent system. The company will launch the stent in Europe and other CE Mark countries immediately.

The stent is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Peripheral vascular disease (PVD) is a circulatory disorder that results from a build-up of plaque in one or more of the arteries of the legs. As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability. In Europe, PVD affects 13 million people or one in 20 people older than 40 years of age.

The Innova stent system consists of a nitinol (a metal alloy of nickel and titanium), self-expanding, bare-metal stent loaded on a low-profile delivery system. The architecture features a closed-cell design at each end of the stent for more consistent deployment, and an open-cell design along the stent body for improved flexibility. The stent features a tri-axial catheter shaft designed to provide added support and placement accuracy as well as radiopaque markers to enhance visibility. The stent is 6F compatible and is available in sizes from 5 mm to 8 mm in diameter and 20 mm to 200 mm in length.

“Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates,” said Mauro Gargiulo, M.D., physician at Sant’Orsola-Malpighi in Bologna, Italy, who performed the first procedure using the Innova stent in Europe. “The unique design and stent architecture used in the Innova Stent platform provide excellent radial strength, flexibility and durability which are critical to sustaining patency in treated SFA and PPA lesions.”

The stent is not available in the United States yet, but patient enrollment continues in the SuperNOVA clinical trial to support the company’s application for U.S. Food and Drug Administration approval of the device.
This prospective, single-arm, non-randomized trial evaluates the safety and effectiveness of the Innova Stent in patients with stenosis of the SFA, PPA, or both. Enrollment is planned for up to 300 patients at 50 sites in the United States, Canada and Europe, and the expected date of completion is within the first half of 2013.

Boston Scientific is based in Natick, Mass.