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February 1, 2011 – A self-anchoring aortic heart valve has received the CE mark. With the approval, the Perceval S Sutureless biological valve, by the Sorin Group, is now commercially available in Europe.

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January 31, 2011 – Parental history of heart disease nearly doubles a person’s risk in all regions of the world, even after considering all other known risk factors of heart disease. The results come from a study published in the Feb. 1, 2011, issue of the Journal of the American College of Cardiology.

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January 31, 2011 – The first successful transcatheter implantation of a 27 mm transapical aortic valve prosthesis has been completed. The procedure was performed by Hendrik Treede, M.D., at the University Heart Center Hamburg using JenaValve’s transcatheter aortic valve implantation (TAVI) system. It was part of the company’s ongoing pivotal CE mark trial

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Technology

January 31, 2011 – A new catheter used to treat coronary artery disease has received regulatory clearance in the United States and approval in Japan. The Trek and Mini-Trek systems, by Abbott, are used in angioplasty procedures and are designed to enable interventional cardiologists to open patients' narrowed coronary arteries. The Trek system received the CE mark in May 2010.

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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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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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