Boston Scientific has completed patient enrollment in the Supernova trial designed to evaluate the long-term (12 month) safety and effectiveness of the Innova self-expanding stent system (Innova stent system).
The single arm, prospective, multicentre trial, which enrolled 299 patients at 51 sites in the US, Canada, Japan and Europe, is expected to support regulatory submissions in the US, Canada and Japan.
Innova stent is designed for treating patients with a narrowing or blockage of the arteries above the knee, often associated with peripheral artery disease (PAD).
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 body provides enhanced flexibility, radial strength and fracture resistance due to its closed-cell design and uniform, open-cell structure.
A tri-axial catheter shaft of the Innova system will offer added support and placement accuracy, as well as radiopaque markers to increase visibility.
Boston Scientific peripheral interventions president, Jeff Mirviss, noted peripheral artery disease affects millions of people globally, diminishing their quality of life and putting them at increased risk of limb amputation, stroke, heart attack and even death.
"The Innova Stent System is specifically designed for use in the Sfa and PPA and we expect it will provide physicians with a new alternative to treat peripheral artery disease in the challenging vascular environment above the knee," Mirviss said.
The Innova Stent System received CE Mark approval in May 2012, however, it is still an investigational device and not available for sale in the US.
Peripheral vascular disease (PVD) is a circulatory disorder that results from a build-up of plaque in one or more of the arteries of the legs.
Globally, more than 27 million people suffer from PAD.
Image: Innova self-expanding bare-metal stent system. Photo: courtesy of Boston Scientific