Boston Scientific announced the start of patient enrolment in the SuperNOVA clinical trial, an international, prospective, single-arm, non-randomised trial evaluating the safety and effectiveness of the Innova self-expanding bare-metal stent system in patients with stenosis of the superficial femoral artery (SFA) or proximal popliteal artery (PPA).
Enrolment is planned for up to 300 patients at 50 sites in the USA, Canada and Europe. The first patient was enrolled by Subhash Banerjee, associate professor of medicine and chief of Cardiology at the VA Medical Center in Dallas, Texas, USA.
The Innova stent system 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 innovative 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 does not 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. This stent is 6F compatible and ranges from 5mm to 8mm in diameter and 20mm to 200mm 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, section chief of Vascular Surgery at Dartmouth-Hitchcock Medical Center in Lebanon and global principal investigator of the 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 Innova stent system received CE mark in March 2011, and the company plans to begin marketing the product in the EU and other countries in the second quarter of 2011. In the USA, it is an investigational device, limited by applicable law to investigational use only and not available for sale.