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Boston Scientific has recently acquired FDA approval for its Innova Vascular Self-Expanding Stent System for treating peripheral artery disease (PAD).
“This is an important therapy for a disease that can have life-changing consequences, including limb amputation,” said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. “The Innova and the Eluvia Stent Systems together demonstrate our commitment to improving health outcomes in the treatment of a disease affecting more than 200 million people worldwide.”
Looking forward, Boston Scientific says the bare-metal Innova will be the platform for its drug-eluting Eluvia vascular stent, designed for the superficial femoral artery. The investigational Eluvia does not have FDA or CE mark approval. Eluvia would compete with Cook Medical’s Zilver PTX drug-eluting stent for PAD, which earned FDA approval in 2012.
“It is gratifying to be able to offer this minimally invasive therapy to improve the quality of life in those patients who suffer from PAD,” said Richard Powell, M.D., section chief, Department of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, N.H., professor of Surgery and Radiology at the Geisel School of Medicine, and global principal investigator of the SuperNOVA trial, evaluating the safety and effectiveness of the Innova Stent System. “The SFA and proximal popliteal arteries present a challenging environment for stents. The flexibility, radial strength and fracture resistance of the Innova Stent are designed specifically for this anatomy.”
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
For Further Information
More on the markets for peripheral vascular devices in the US and Europe can be found in this latest edition report published by iData entitled U.S. & European Peripheral Vascular Stents and Stent Grafts Devices Market, which covers the US and 15 countries in Europe, as well as 500 market sub-segments by country for peripheral vascular stents, PTA balloon catheters, atherectomy devices, chronic total occlusion devices, embolic protection devices, stent-grafts, surgical grafts, AV access thrombectomy devices, inferior vena cava filters, diagnostic and interventional catheters, standard and hydrophilic guidewires, introducer sheaths, vascular closure devices, and transcatheter embolization devices.
The iData series on the market for peripheral vascular devices also covers the U.S., China, India, Japan, and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
Register online or email us at [email protected] for a U.S. & European Peripheral Vascular Stents and Stent Grafts Devices Market report brochure and synopsis.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by State, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.
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