Boston Scientific has gained CE Mark for its 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 Natick, Mass.-based company plans to launch the product immediately in Europe and other CE Mark countries.
The Innova stent system consists of a nitinol, self-expanding, bare-metal stent loaded on 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. Innova is 6F compatible and is available in sizes from 5 mm to 8 mm in diameter and 20 mm to 200 mm in length.
Patient enrollment continues in the SuperNOVA clinical trial to support the company’s application for FDA approval of Innova. This prospective, single-arm, non-randomized trial evaluates the safety and effectiveness of Innova in patients with stenosis of the SFA, PPA or both. Enrollment is planned for up to 300 patients at 50 sites in the U.S., Canada and Europe, and is expected to be completed in the first half of 2013.
In the U.S., Innova is an investigational device, limited by applicable law to investigational use only and not available for sale.