Boston Scientific has initiated patient enrollment in the SuperNOVA clinical trial, an international, prospective, single-arm, non-randomized trial evaluating the safety and effectiveness of the INNOVA Self-Expanding Bare-Metal Stent System in patients with stenosis of the superficial femoral artery (SFA) or proximal popliteal artery (PPA).
Enrollment is planned for up to 300 patients at 50 sites in the US, Canada and Europe.
The INNOVA Stent System consists of a nitinol, self-expanding bare-metal stent loaded on an advanced low-profile delivery system.
Boston Scientific said stent deliverability is enhanced with a tri-axial catheter shaft designed to provide added support and placement accuracy as well as dual deployment options and radiopaque markers to enhance ease of use.
The INNOVA Stent is 6F compatible and ranges from 5 mm to 8 mm in diameter and 20 mm to 200 mm in length.
Boston Scientific Endovascular Unit senior vice president and president Joe Fitzgerald said the stent’s design is intended to improve blood flow and provide greater long-term stent durability, ultimately improving the overall quality of life for patients with peripheral artery disease.
The INNOVA Stent System received CE mark in March, and Boston Scientific plans to begin marketing the product in the EU and other countries in the second quarter of 2011.
In the US, it is an investigational device, limited by applicable law to investigational use only and not available for sale.