Boston Scientific Begins SuperNOVA Trial

April 5, 2011—Boston Scientific Corporation (Natick, MA) announced the start of patient enrollment in the SuperNOVA clinical trial. SuperNOVA is an international, prospective, single-arm, nonrandomized trial evaluating the safety and effectiveness of the company's Innova self-expanding bare-metal stent system in patients with stenosis of the superficial femoral artery or proximal popliteal artery. The trial plans to enroll up to 300 patients at 50 sites in the United States, Canada, and Europe. Richard J. Powell, MD, is principal investigator of SuperNOVA.

According to Boston Scientific, the Innova stent system is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery and proximal popliteal artery. The nitinol self-expanding bare-metal stent is loaded on a low-profile delivery system. The device features a closed-cell design at each end of the stent to improve radial force and fracture resistance, an open-cell design along the stent body for flexibility, a triaxial catheter shaft, dual deployment options, and radiopaque markers. The Innova stent is 6-F compatible and ranges from 5 to 8 mm in diameter and 20 to 200 mm in length.

The Innova stent system received CE Mark approval in March. The company plans to begin marketing the product in the European Union and other countries in the second quarter of 2011. In the United States, it is an investigational device that is limited by applicable law to investigational use only and is not available for sale, the company advised.