Corevalve beats surgery, ACC 2014, TAVR vs surgery, Edwards lawsuit
Feature | Dave Fornell

The U.S. District Court for the District of Delaware granted a preliminary injunction limiting the sale of Medtronic's CoreValve transcatheter aortic valve replacement (TAVR) system in the United States. The court ordered the injunction April 10.

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April 15, 2014 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) clearance of two new mechanical lead extraction platforms that expand physicians' options for the safe removal of cardiac leads. Each incorporates innovative designs for mechanical extraction aimed at providing total lead management solutions.

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April 15, 2014 — NEC Display Solutions of America announced U.S. Food and Drug Administration (FDA) 510(k) market clearance of the 30-inch MultiSync MD302C4 LCD, a widescreen display for diagnostic review applications in healthcare organizations.

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The U.S. Food and Drug Administration (FDA) granted 510(k) market clearance for the GE Healthcare Revolution computed tomography (CT) system. The 256-slice CT system offers technology that provides excellent image quality and clinical capabilities through the convergence of coverage, spatial resolution and temporal resolution.

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Fujifilm Medical Systems U.S.A. Inc. highlighted an integrated Synapse portfolio that allows cardiologists and clinical professionals to enhance patient care through optimized productivity at the 63rd Annual Scientific Session of the American College of Cardiology (ACC) March 29-31 in Washington, D.C.

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Roughly one out of three children screened for high cholesterol between the ages of 9 and 11 has borderline or high cholesterol, potentially placing them at greater risk for future cardiovascular disease, according to research to be presented at the American College of Cardiology’s 63rd Annual Scientific Session.

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April 14, 2014 — CardiacAssist announced it has received a Class 4 medical device license for its TandemHeart system from Health Canada. The TandemHeart system is now licensed to provide up to 10 days of circulatory support in patients with reduced left ventricular function and limited pre-operative/pre-procedure ejection fraction (EF) and/or with a high risk of post-operative/post-procedure low output syndrome.

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April 14, 2014 — Biotronik recently announced CE approval for its new Eluna pacemaker series. The new generation of pacemakers includes single- and dual-chamber as well as cardiac resynchronization (CRT-P) devices.

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April 11, 2014 — Calgary Scientific Inc. announced their latest Class II clearance from the U.S. Food and Drug Administration (FDA). Its enterprise image-viewing solution, ResolutionMD, is now cleared for diagnosis on mobile devices for all imaging modalities. This builds upon their previous clearances for diagnosis using web, iOS and Android devices.

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April 11, 2014 — Medtronic announced CE mark and European launch of the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system, the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body. The Medtronic Evera MRI ICD is not approved in the United States.

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April 11, 2014 — Boston Scientific Corp. has expanded the launch of its S-ICD (subcutaneous implantable cardioverter-defibrillator) system into parts of Asia. The first implant of the S-ICD in Asia was performed in Hong Kong by Hung-Fat Tse, professor of cardiovascular medicine, University of Hong Kong, and department of medicine, Queen Mary Hospital in Pokfulam, Hong Kong.

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Cardiologists at Arnold Palmer Hospital for Children performed Florida’s first pediatric implant of a new device to prevent sudden cardiac arrest.

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Mitralign Inc. has completed enrollment in a study in Europe investigating its lead device, the Mitralign System, in patients with functional mitral regurgitation (FMR).

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April 10, 2014 — CardioKinetix Inc. announced results of a pooled analysis study of the catheter-based Parachute ventricular partitioning device. Twelve-month clinical results from 111 consecutive U.S. and European patients with ischemic heart failure were presented at the 2014 annual meeting of the American College of Cardiology (ACC) by Philip Adamson, medical director at the Heart Failure Institute at Oklahoma Heart Hospital.

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April 10, 2014 — The 2014 Guideline for the Management of Patients With Atrial Fibrillation includes recommendations for an increased use of radio frequency (RF) ablation in the treatment of non-valvular atrial fibrillation, the addition of three new anticoagulants to treatment options, a diminished role in the use of aspirin and a more comprehensive risk calculator.

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