April 13, 2011 – Patient enrollment has begun for the SuperNOVA clinical trial. It will examine the safety and effectiveness of Boston Scientific’s Innova self-expanding bare-metal stent in patients with stenosis of the superficial femoral artery (SFA) or proximal popliteal artery (PPA).
Enrollment is planned for up to 300 patients at 50 sites in the United States, Canada and Europe. The first patient was enrolled in the trial by Subhash Banerjee, M.D., associate professor of medicine and chief of cardiology at the VA Medical Center in Dallas, Texas.
The stent is designed to treat peripheral vascular lesions in arteries above the knee, specifically the SFA and PPA. It consists of a nitinol, self-expanding bare-metal stent loaded on an advanced low-profile delivery system. The architecture features a closed cell design at each end of the stent for improved radial force and fracture resistance, and an open cell design along the stent body that doesn't compromise flexibility. Stent deliverability is enhanced with a tri-axial catheter shaft designed to provide added support and placement accuracy, as well as dual deployment options and radiopaque markers to enhance ease of use. The stent is 6 French compatible and ranges from 5 to 8 mm in diameter and 20 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 Richard J. Powell, M.D., section chief of vascular surgery at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and global principal investigator of the SuperNOVA trial. "I believe the Innova Stent offers a unique design that provides excellent radial strength while remaining flexible and durable, which is critical to sustaining patency in treated SFA and PPA lesions."
"The Innova Stent is engineered to offer an advanced solution in treating blockages within these critical arteries," said Joe Fitzgerald, senior vice president and president of Boston Scientific's endovascular unit. "Its design is intended to improve blood flow and provide greater long-term stent durability, ultimately improving the overall quality of life for patients with peripheral artery disease."
The system received CE mark in March, and the company plans to begin marketing the product in the EU and other countries in the second quarter of 2011. In the United States, it is an investigational device, limited by applicable law to investigational use only and not available for sale.
For more information: www.bostonscientific.com