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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.
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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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January 21, 2011 – Intravascular ultrasound (IVUS) enabled physicians to more accurately assess the risk of individual blockages than the use of the current standard of angiographic imaging alone, according to a new study.

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January 20, 2011 – European CE mark approval was granted to expand the indication of Abbott’s Xience Prime everolimus-eluting coronary stent for the treatment of critical limb ischemia (CLI) or severe claudication (pain) of the lower leg. CLI is the most advanced form of peripheral artery disease (PAD) that can ultimately lead to limb amputation.

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The Society for Cardiovascular Angiography and Interventions (SCAI) this week published guiding principles and best practices for the development of radiation safety programs in cardiac catheterization laboratories.

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January 20, 2011 – Results from a large, worldwide, clinical trial show evidence that a first-of-its-kind pacemaker system is safe and effective to use during magnetic resonance imaging (MRI). During the trial, no MRI-related complications were reported in patients with the pacemaker system before, during, or after an MRI examination.

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Continuing to build a portfolio of transcatheter structural heart technology, Boston Scientific today signed a definitive merger agreement to acquire Atritech Inc. Atritech developed the Watchman device, which is designed to close the left atrial appendage (LAA) in patients with atrial fibrillation who are at risk for ischemic stroke.

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January 19, 2011 – The patient support group Mended Hearts, in partnership with Daiichi Sankyo Inc. and Eli Lilly and Company, this week launched the Stent Hub – an online patient and caregiver resource for acute coronary syndrome (ACS) patients who were treated with percutaneous coronary intervention (PCI).

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Technology

January 19, 2011 – GE Healthcare and Veran announced a strategic supplier agreement this week in which GE became the exclusive distributor and reseller of Veran’s ig4 fusion imaging angiography navigation system in the United States.

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January 19, 2011 – The U.S. Food and Drug Administration (FDA) granted conditional approval to modify the CoreValve U.S. pivotal clinical trial to eliminate the medical management arm of the study.

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