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January 31, 2011 – The U.S. Food and Drug Administration (FDA) has approved a system for accessing and delivering diagnostic, embolic and therapeutic materials into the peripheral vasculature. The Renegade HI-FLO Fathom Pre-Loaded System, by Boston Scientific, will be used by interventional radiologists for minimally invasive procedures to treat uterine fibroids and liver cancer.

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January 28, 2011 – The Civil Division of the U.S. Department of Justice (DOJ) filed a civil False Claims Act lawsuit against Boston Scientific, Guidant LLC and other entities seeking additional payments related to faulty implantable cardioverter defibrillators (ICDs).

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January 27, 2011 – The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) Supplement allowing more patients to participate in the ADVANCE trial. The bridge-to-transplant will let a third allotment of 94 more patients under a Continued Access Protocol (CAP).

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January 27, 2011 – The first U.S.-procedure to use a new open-irrigated catheter was completed as part of the BLOCk-CTI trial. The study is using Boston Scientific’s Blazer Open-Irrigated Catheter to evaluate its safety and effectiveness in patients with sustained or recurrent type 1 atrial flutter.

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January 27, 2011 – The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee agreed this week that carotid stenting was safe for patients at standard surgical risk.

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January 27, 2010 – The U.S. Food and Drug Administration (FDA) expanded the indication for the Bard Peripheral Vascular LifeStent and LifeStent XL nitinol self-expanding stents for the treatment of lesions up 240 mm in length.

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January 27, 2011 – The U.S. Food and Drug Administration (FDA) granted conditional investigational device exemption (IDE) approval to evaluate the safety and effectiveness of a cath lab robotic navigation system to direct guidewires and place coronary stents.

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January 27, 2010 – An ergonomic, peel-away introducer sheath was launched this week to facilitate placement of electrophysiology device leads and catheters in the venous system.

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January 26, 2011 – Patient enrollment has begun in China for a trial evaluating the safety and effectiveness of a next-generation stent. The PLATINUM China clinical trial will look at the Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent, by Boston Scientific, for treating patients with a single de novo atherosclerotic lesion.

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January 26, 2011 - The University of Michigan Cardiovascular Center and the University of Pittsburgh have been awarded $13.3 million to explore the potential benefits of heart devices for the large and growing group of Americans with heart failure.

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January 25, 2011 – A microcatheter offering superior crossability, flexibility and guidewire support during coronary and peripheral catheterization procedures was released this week by Vascular Solutions Inc.

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Manufacturing costs will always be a paramount consideration in producing products, as indicated by the enormous number of goods sent offshore for manufacturing by U.S. companies and many others.

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January 25, 2011 – The cost to treat heart disease in the United States will triple by 2030, according to a policy statement published in Circulation: Journal of the American Heart Association.

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January 25, 2011 — Royal Philips Electronics has announced CE marking for the industry’s first commercially available whole-body positron emission tomography/magnetic resonance (PET/MR) imaging system, the Ingenuity TF PET/MR. The system is pending 510(k) and not available for sale in the U.S.

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