Innova bare-metal stent gets CE mark


Boston Scientific has announced CE mark and European market launch of 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).

“Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates,” said Mauro Gargiulo, Sant’Orsola-Malpighi, Bologna, Italy, who performed the first procedure using the Innova stent 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.”

The Innova stent system 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 more consistent deployment, and an open-cell design along the stent body for improved flexibility. Deployment accuracy is enhanced with a tri-axial catheter shaft designed 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 from5mm to 8mm in diameter and 20mm to 200mm in length.

Patient enrolment continues in the SuperNOVA clinical trial to support the company’s application for Innova’s FDA approval. This prospective, single-arm, non-randomised trial evaluates the safety and effectiveness of the Innova stent in patients with stenosis of the SFA, PPA, or both. Enrolment is planned for up to 300 patients at 50 sites in the USA, Canada and Europe, and is expected to be completed in the first half of 2013.