EC clears Boston Innova bare-metal stent system
The European Commission (EC) has granted CE-mark approval for Boston Scientific's 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 6F compatible Innova stent system comprises a nitinol, self-expanding, bare-metal stent loaded on an advanced low-profile delivery system and is available in sizes from 5mm to 8mm in diameter and 20mm to 200mm in length.
The stent system features a closed-cell design at each end of the stent for consistent deployment and an open-cell design along the stent body for improved flexibility.
A tri-axial catheter shaft of the Innova system will offer added support and placement accuracy as well as radiopaque markers to increase visibility.
Mauro Gargiulo, physician at the Sant'Orsola-Malpighi Polyclinic in Bologna, Italy, said treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates.
"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," Gargiulo added.
"The excellent deliverability and placement accuracy add another significant level of benefit, especially when accessing challenging and long lesions."
Boston Scientific peripheral interventions division president Jeff Mirviss said the Innova stent is designed to provide an advanced solution for treating blockages within the critical arteries.
"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," Mirviss added.
The company is planning to enrol up to 300 patients into the prospective single-arm, non-randomised SuperNOVA clinical trial of the Innova stent system, the data from which will support Boston's application for US Food and Drug Administration approval.
Patient enrolment in the SuperNOVA study is likely to be concluded in the first half of 2013.
Image: The Innova self-expanding bare-metal stent system from Boston Scientific is now available in Europe. Photo courtesy of: Frank C. Müller.