Boston Scientific has received CE mark approval for its Innova Self-Expanding Bare-Metal Stent system to treat peripheral vascular lesions in superficial femoral artery (SFA) and proximal popliteal artery (PPA).
The Innova system includes a self-expanding, bare-metal Nitinol stent which features a closed-cell design at each end for easy deployment and an open-cell design along the body for improved flexibility.
A tri-axial catheter shaft is added to the system to provide added support and placement accuracy as well as radiopaque markers to enhance visibility.
The Innova 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.
Boston Scientific peripheral interventions division president Jeff Mirviss said, "This next-generation stent technology is designed to offer physicians improved acute performance and excellent long-term stent durability, intended to improve overall quality of life for patients with peripheral artery disease."
Patient enrollment continues in the SuperNOVA clinical trial to support the company’s application for US Food and Drug Administration approval of the Innova Stent system.
The prospective, single-arm, non-randomized trial is designed to assess 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 and is expected to be completed in the first half of 2013.
The Innova Stent system is an investigational device and not available for sale in the US.