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C.R. Bard recently announced that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease.
The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said.
“C. R. Bard is proud to build upon its vast history and experience in angioplasty balloons, stents and covered stents to offer physicians this new option,” chairman & CEO Timothy Ring said in prepared remarks. “The LifeStream covered stent expands the continuum of care available for physicians who trust and rely on Bard products.”
“Intervention in the iliac arteries is a complex and delicate process, and accurate implant placement is especially important given that these arteries control the blood flow for a patient’s entire leg,” added Dr. John Laird of Sacramento’s University of California – Davis Medical Center, principal investigator for the Bolster study backing Bard’s PMA bid. “The LifeStream covered stent enabled physicians to achieve accurate device placement and a durable treatment effect in patients with PAD treated for iliac artery lesions.”
Bard said the 255-patient Bolster study showed a target lesion revascularization rate of 3.9% and a major adverse event rate of 4.7% at 9 months. The trial beat its primary endpoint, a composite safety and effectiveness measure that set an objective performance goal of 19.5%, showing 11.6% on a post-hoc basis and 16.2% on a pre-specified basis.
Bard said the LifeStream device is on the U.S. market and has been available in Europe since 2014.
For Further Information
More on the peripheral vascular stent market in the U.S. can be found in a report series published by iData Research entitled the US Peripheral Vascular Device Market – 2016″>U.S. Markets for Peripheral Vascular Devices and Accessories Report Suite. The suite covers reports on the following markets: Peripheral Vascular Stent Market, PTA Balloon Catheter Market, Atherectomy Device Market, Chronic Total Occlusion (CTO) Device Market, Embolic Protection Device Market, Stent Graft Market, Surgical Graft Market, Diagnostic and Interventional Catheter Market, Diagnostic and Interventional Guidewire Market, Introducer Sheath Market, Inferior Vena Cava Filter Market, Arteriovenous (AV) Access Thrombectomy Device Market, Vascular Closure Device Market, and Transcatheter Embolization Device Market.
The iData report series on peripheral vascular devices covers the U.S., Japan, China, India, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports also 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. To find out more about peripheral vascular device market data or procedure data, register online or email us at [email protected] for a US Peripheral Vascular Device Market – 2016″>U.S. Markets for Peripheral Vascular Devices and Accessories Report Suite brochure and synopsis.