News | May 17, 2012

Boston Scientific Gains CE Mark for Innova Self-Expanding Peripheral Stent

Innovative stent designed to treat peripheral vascular lesions for stenoses in arteries above the knee

May 17, 2012 — Boston Scientific Corp. announces 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). The company plans to launch the product immediately in Europe and other CE mark countries. 

"Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates," said Mauro Gargiulo, M.D., physician at Sant'Orsola-Malpighi in 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 6 French compatible and is available in sizes from 5-8 mm in diameter and 20-200 mm in length.

"The Innova Stent is engineered to offer an advanced solution to treat blockages within these critical arteries," said Jeff Mirviss, president of Boston Scientific's peripheral interventions division. "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."

Patient enrollment continues in the SuperNOVA clinical trial to support the company's application for U.S. Food and Drug Administration approval of the Innova Stent System. This prospective, single-arm, non-randomized trial evaluates the safety and effectiveness of the Innova Stent in patients with stenosis of the SFA, PPA, or both. Enrollment is planned for up to 300 patients at 50 sites in the United States, Canada and Europe, and is expected to be completed in the first half of 2013. 

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. As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability. In Europe, PVD affects 13 million people or one in 20 people over 40 years old.

In the United States, the Innova Stent System is an investigational device, limited by applicable law to investigational use only and not available for sale. 

For more information:


Related Content

First European Patient Enrolled in Intact Vascular's TOBA II BTK Trial
News | Stents Peripheral | July 26, 2017
Intact Vascular Inc. recently announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK)...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral | July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
New Twelve-Month Data Show Efficacy of Pulsar-18 Bare Metal Stent
News | Stents Peripheral | April 28, 2017
Biotronik’s Pulsar-18 bare metal stent (BMS) has yielded high primary patency in a real-world setting, according to the...
Gore Tigris Vascular Stent, Health Canada approval, PAD, peripheral artery disease
News | Stents Peripheral | March 16, 2017
W. L. Gore & Associates Inc. recently announced the Health Canada approval of the Gore Tigris Vascular Stent, a...
TOBA II BTK clinical trial, Intact Vascular, Tack Endovascular System, CLI, critical limb ischemia, first patient treated
News | Stents Peripheral | March 02, 2017
Intact Vascular Inc. announced in February that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK)...
Biotronik, Pulsar-18 bare metal self-expanding stent, BMS SE, BIOFLEX PEACE trial, 12-month results, VEITHsymposium 2016
News | Stents Peripheral | December 13, 2016
Biotronik announced the presentation of data confirming the efficacy of the Pulsar-18 bare metal self-expanding stent (...
LimFlow System, critical limb ischemia, CLI, CE Mark
News | Stents Peripheral | December 08, 2016
LimFlow SA announced in November that it received the CE Mark for its fully percutaneous LimFlow System designed for...
Gore, Tigris stent, fluoropolymer nitinol stent, peripheral artery disease

The Gore Tigris is a dual-component stent with a unique fluoropolymer / nitinol design.

Technology | Stents Peripheral | August 02, 2016
August 2, 2016 —The U.S. Food and Drug Administration (FDA) granted market clearance for W. L.
Technology | Stents Peripheral | April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Boston Scientific, Eluvia vascular stent system, CE Mark, peripheral artery disease
News | Stents Peripheral | March 17, 2016
Boston Scientific announced in late February that the Eluvia Drug-Eluting Vascular Stent System received CE Mark, and...
Overlay Init