Boston Scientific’s Innova BMS System Approved and Launched in EU
May 14, 2012—Boston Scientific Corporation (Natick, MA) announced that it has received CE Mark approval for the Innova self-expanding bare-metal stent system, which is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The company will launch the device immediately in Europe and other countries that recognize the CE Mark.
“Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates,” commented Mauro Gargiulo, MD, in the company’s press release. Dr. Gargiulo, of Sant’Orsola-Malpighi in Bologna, Italy, performed the first procedure using the Innova stent system 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 excellent deliverability and placement accuracy add another significant level of benefit, especially when accessing challenging and long lesions.”
According to Boston Scientific, the Innova stent system consists of a nitinol, self-expanding, bare-metal stent that is loaded onto 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 triaxial catheter shaft is designed to provide added support and placement accuracy. The device also includes radiopaque markers that enhance visibility. The Innova stent is 6 F compatible and available in sizes from 5 to 8 mm in diameter and 20 to 200 mm in length, the company stated.
Boston Scientific’s announcement also included that patient enrollment is continuing in the SuperNOVA clinical trial to support the company’s application for US Food and Drug Administration approval of the Innova stent system. In the United States, the Innova stent system is an investigational device that is limited by applicable law to investigational use only and is not available for sale.
SuperNOVA is a prospective, single-arm, nonrandomized trial evaluating the safety and effectiveness of the Innova stent system in patients with stenosis of the SFA, PPA, or both. The company stated that it plans to enroll up to 300 patients at 50 sites in the United States, Canada, and Europe. Enrollment is expected to be completed in the first half of 2013, according to Boston Scientific.