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November 4, 2011 – PhysioSonics announced that it received a $2.5 million grant from the Telemedicine and Advanced Technology Research Center (TATRC). TATRC is an organization within the headquarters of the U.S. Army Medical Research and Materiel Command, located at Fort Detrick, Maryland. With this grant, PhysioSonics will optimize its proprietary cerebral blood-flow monitor to detect vasospasm. Following a successful launch in the civilian healthcare market, the military will test the blood-flow monitor with the goal of deploying it at military facilities that care for soldiers with traumatic brain injuries (TBI).

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November 4, 2011—Miracor Medical Systems GmbH announced that data will be reported during next week’s Transcatheter Cardiovascular Therapeutics (TCT) 2011 scientific meeting in San Francisco. The data show that the PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) system is safe and feasible during elective percutaneous coronary intervention (PCI) using a femoral vein approach.

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November 4, 2011 – W. L. Gore & Associates announced that Royal Sussex County Hospital in Brighton, United Kingdom, is the first medical center in the United Kingdom to enroll a patient in the Gore REDUCE clinical study. The study is a U.S. Food and Drug Administration (FDA)-approved prospective, randomized, multi-center, international trial designed to demonstrate safety and effectiveness of the Gore HELEX septal occluder for patent foramen ovale (PFO) closure in patients with a history of cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA). The unique study includes up to fifty investigational sites in the United States and Europe. This patient enrollment was achieved by the site’s study investigator, David Hildick-Smith, M.D., director of cardiac research unit, Brighton and Sussex University Hospitals.

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November 4, 2011 - Cardiology departments have hosted a variety of software solutions in the past to meet varying demands. A new report from KLAS reveals the cardiology IT market is moving toward consolidation. The report, Cardiology 2012: Will the Complete CVIS Please Stand Up?, explains that as a result of the trend toward consolidation, providers are looking for a technology leader to step up and meet their needs.

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Technology

November 4, 2011 — Medtronic Inc. announced approval by the U.S. Food and Drug Administration (FDA) of the Assurant Cobalt Iliac Balloon-Expandable Stent System.

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November 4, 2011 — The U.S. Food and Drug Administration (FDA) has approved a stent graft system for patients with small arteries; it will give them the option of less invasive surgery to repair their potentially life-threatening abdominal aortic aneurysm.

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Cerner cardiovascular solutions enable cardiologists to automate functions across the continuum of care. Built upon the Cerner Millennium architecture, Cerner’s PowerChart Cardiovascular solution unifies cardiovascular diagnostic activities, therapeutic interventions and follow-up regimens into a single workflow, integrated with the electronic health record (EHR). PowerChart Cardiovascular gives the cardiologist the ability to view images in context with Cerner’s cardiovascular workflow manager utilizing the integration with the Merge viewer.

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November 3, 2011 – Medtronic announced the first implant in a clinical trial in Japan that will evaluate the safety and effectiveness of the Medtronic CoreValve System.

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November 3, 2011 – Lantheus Medical Imaging announced important changes to the U.S. product label for Definity Vial for (perflutren lipid microsphere) Injectable Suspension. The contrast agent is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

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November 3, 2011 – New study indicates strong diagnostic ability of treadmill exercise stress testing to uncover Long QT syndrome (LQTS) in patients. Here, investigators from the Mayo Clinic show how the recovery phase displays significant and maladaptive changes in the QTc unveiling the most common LQTS type, LQT1. The study, published in the November edition of HeartRhythm, the official journal of the Heart Rhythm Society, is the largest, single-center study of treadmill exercise stress testing in patients with genetically proven LQTS as well as those who were dismissed as normal.

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The U.S. Food and Drug Administration (FDA) today approved the first transcatheter aortic heart valve in the United States - the Sapien THV. Experts say the approval will open a new chapter in how patients with severe aortic valve stenosis will be treated, without surgery.

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The U.S. Food and Drug Administration (FDA) granted market clearance for the Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease. The stent uses the same drug and biocompatible polymer as the Xience V everolimus-eluting coronary stent system, but features an enhanced stent design and a delivery system designed for greater flexibility, better radial strength, longitudinal strength and more accurate stent placement.

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November 1, 2011 – CardioComm Solutions, a provider of hardware and software solutions for cardiovascular health management, announced the extension of their current OEM agreement with GE Healthcare. The agreement renewal means both companies will continue to play a role in the expanding cardiovascular monitoring and diagnostic devices segment, forecast recently by MarketResearch.com to grow a compound annual growth rate (CAGR) of 5 percent between now and 2017.

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Philips TruFlight Select is its first economical positron emission tomography/computed tomography (PET/CT) system equipped premium time-of-flight (TOF) technology, Astonish TF. Competitive systems with similar performance can cost up to $500,000 more than the TruFlight Select PET/CT.

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November 1, 2011 – Claret Medical Inc. said its Montage System has received CE mark approval as the world's first complete system of filtration to protect both carotid arteries simultaneously. The 6 French catheter is delivered via radial or brachial access, providing complete neuro protection during intravascular procedures such as transcatheter aortic valve intervention (TAVI). The unique design of the Montage System not only provides neuro-protection from debris, but also captures and removes potential stroke-causing embolic material from the body.

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