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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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Technology

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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Technology

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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Feature

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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January 24, 2011 – Boston Scientific has reached an agreement with Fukuda Denshi to market and sell its cardiac rhythm management (CRM) devices and accessories throughout Japan. Fukuda Denshi will begin distributing the CRM products this quarter. Fukuda Denshi has been operating in Japan for more than 70 years. For more information: www.bostonscientific.com

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January 24, 2011 – Lantheus Medical Imaging has entered into a contract with Novation for Ablavar (gadofosveset trisodium) and Definity Vial for Injectable Suspension (Perflutren Lipid Microsphere). The agreement will provide increased access to the diagnostic imaging agents for healthcare providers served by Novation.

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January 24, 2011 – A new device for treating peripheral artery disease (PAD) is now available in Europe. W.L. Gore and Associates announced the availability of its Viabahn Endoprosthesis on a lower profile delivery system at the Leipzig Interventional Course in Germany.

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January 24, 2011 – Patient enrollment was completed in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Boston Scientific's fourth-generation Synergy coronary stent, which uses a bioabsorbable drug-eluting polymer.

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January 24, 2011 – The first U.S. clinical implant of a device designed to restore more natural breathing patterns in patients with central sleep apnea was made last week at The Ohio State University Medical Center, Columbus.

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The microbubbles that make up the ultrasound contrast agent Optison from GE Healthcare.
Feature

http://www.echocontrast.nl/Contrast-enhanced ultrasound (CEUS) can "dramatically improve" physicians' ability to detect heart disease and stratify future risk, said Thomas Porter, M.D., at the 16th European Symposium on Ultrasound Contrast Imaging in Rotterdam.

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January 21, 2011 – The U.S. Food and Drug Administration (FDA) this week unveiled a plan containing 25 actions it intends to implement during 2011 to improve its 510(k) review of medical technology, the most common path to market for medical devices.

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