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October 3, 2011 – Cardiac Dimensions Inc. announced it received European CE mark approval for a newly enhanced version of its Carillon Mitral Contour System, a therapy for treating heart failure patients suffering from functional mitral regurgitation (FMR). Receipt of the CE mark enables Cardiac Dimensions to initiate a commercial launch of the enhanced device in Europe, which will begin in 2012.

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October 3, 2011 – Boston Scientific has enrolled the first patients in its NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) clinical trial. NECTAR-HF is a prospective, randomized, international clinical feasibility study designed to assess preliminary safety and efficacy of chronic vagal nerve stimulation in heart failure patients. The study will evaluate 96 patients with vagal nerve stimulator implants at multiple centers in Europe.

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October 3, 2011 – Researchers from MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL), the University of Michigan, Brigham and Women’s Hospital in Boston and Harvard Medical School have developed a new tool that can more accurately determine risk of death in patients who have suffered a heart attack. Results of the study could prove life saving for the millions of Americans who suffer heart attacks every year.

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September 30, 2011 – Cambridge Heart Inc. announced its HearTwave II System was cleared for sale by the Mexican regulatory authorities. In August 2010, the company executed an exclusive distribution agreement with Mayerick S.A. de S.V. to distribute the system, including the company’s microvolt t-wave alternans (MTWA) software and micro-V alternans sensors. This addition represents the company’s first distribution agreement in Latin America.

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September 30, 2011 — The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) released an updated guideline for the diagnosis and management of peripheral artery disease (PAD). The goal is to help guide clinical decision-making related to PAD and improve patient outcomes.

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September 30, 2011 — Boston Scientific Corp. said the U.S. Court of Appeals for the Federal Circuit found in favor of the company in a 1998 stent patent infringement suit involving Johnson & Johnson.

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Technology

September 28, 2011 — Cardiac monitoring company Cardiac Network Inc., along with its joint venture partner Pacific Coast Innovations (PCI) LLC announced it is completing the work on its new Central Monitoring System (CMS). The new system, as described below, was built by the companies relating to the design of a new, technologically advanced monitoring device, related data storage and monitoring infrastructure.

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September 28, 2011 — The 24th annual International Symposium on Endovascular Therapy (ISET) will take place Jan. 15-19, 2012, at the Fontainebleau Miami Beach. More than 1,500 members of the global endovascular community will be in attendance; this includes physicians, researchers, scientists, biomedical engineers, nurses, technologists and other industry professionals. The fields of interventional radiology, interventional cardiology and vascular surgery will be represented, among others.

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September 28, 2011 — A clinical trial by Resverlogix Corp. is evaluating the early effects of a new drug compound in atherosclerotic plaque regression. The study is focused on patients with coronary artery disease who have a low level of high-density lipoprotein cholesterol (HDL-C).

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September 28, 2011 –Ziehm Imaging said its holding company Aton GmbH acquired 100 percent of the United States-based mini C-arm specialist OrthoScan Inc.

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Case Study | Parag V. Patel, DO, FACC, Advocate Lutheran General Hospital, Park Ridge, Ill.

T-wave alternans (TWA) refers to an alternating pattern in the T-wave of the electrocardiogram (ECG) and is recognized as a marker of electrical instability. Visible or macroscopic alternans was first reported in the context of proarrhythmic conditions including Prinzmetal’s angina and long QT syndrome, and was often found to immediately precede the onset of ventricular tachycardia or fibrillation. More recently, techniques have been developed to measure microvolt-level T-wave alternans (MTWA) not visible to the human eye. The presence of MTWA has been linked with increased risk of sudden cardiac arrest (SCA) in several patient populations. This study presents the case of a patient who experienced VF during the recovery phase of an MTWA stress test. While there was no visible abnormality on the ECG which would alert to the impending arrhythmia, significant microvolt-level alternans was detected immediately prior to the cardiac arrest.

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September 27, 2011 – Calgary Scientific Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to market medical imaging application, ResolutionMD Mobile, as a mobile diagnostic application in the United States. With this secure, highly scalable, server-based software solution, physicians anywhere can rapidly access, view and interact with patient images and reports stored within any healthcare facility, and render a clinical diagnosis using their mobile devices. Prior non-diagnostic versions of this product are currently distributed and licensed under original equipment manufacturer (OEM) agreements with global leaders in medical imaging and information technology. In addition to the recent FDA clearance, ResolutionMD Mobile has also been licensed by Health Canada and bears the CE mark for distribution in Europe.

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Toshiba will showcase its proprietary non-contrast magnetic resonance (MR) angiography imaging techniques and a new ...

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Toshiba will showcase the Vantage Titan 3.0T MR system at the 2011 Radiological Society of North America (RSNA) trade show. The machine is equipped with multi-phase transmission technology, creating the most homogeneous abdominal and pelvic images on 3.0T systems.

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September 27, 2011 — AccessClosure Inc. announced the shipment of its one millionth Mynx unit. The Mynx Vascular Closure Device received U.S. Food and Drug Administration (FDA) approval in May 2007, following with its full commercial launch in September 2007.

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