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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.

Home January 21, 2011
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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.

Home January 20, 2011
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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.

Home January 20, 2011
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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.

Home January 19, 2011
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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).

Home January 19, 2011
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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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January 19, 2011 – Stents can open up blocked brain arteries after other stroke treatments have failed, according to research presented this week at the 23rd annual International Symposium on Endovascular Therapy (ISET).

Home January 18, 2011
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January 19, 2011 – Siemens Healthcare is partnering with Endosense for the integration of the contact-force data provided by Endosense’s TactiCath force-sensing ablation catheter with Siemens’ electrophysiology (EP) solutions.

Home January 18, 2011
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January 18, 2011 – The first endovascular device approved for the treatment of pulmonary embolism (PE) was granted CE-mark approval this week in Europe. The Ekos EkoSonic Endovascular System was originally designed and approved to dissolve blood clots in the arms and legs.

Home January 18, 2011
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January 19, 2011 – The U.S. Food and Drug Administration (FDA) this week granted market clearance for Cook Medical’s Formula balloon-expandable renal stent system. The approval includes both the Formula 414RX Renal and the Formula 418 Renal stents.

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January 13, 2011 – A catheter that removes emboli and thrombi from vessels in the coronary and peripheral vasculature has received 510(k) clearance from the U.S. Food and Drug Administration. The Xpress-Way RX manual extraction catheter is manufactured by Kaneka Corp. and distributed by Atrium Medical in the United States.

Home January 13, 2011
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January 13, 2011 – The first patients have been enrolled in a trial evaluating the effectiveness and safety of a force-sensing ablation catheter for treating symptomatic paroxysmal atrial fibrillation (AF). The TOCCASTAR trial will study Endosense’s TactiCath force-sensing ablation catheter.

Home January 13, 2011
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January 13, 2011 – Enrollment has finished for the ORION trial designed to test the Epic self-expanding nitinol stent to treat iliac artery disease. The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at nine months in 125 patients at 28 sites in the United States.

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January 13, 2011 – HeartWare International has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for its ventricular assist system. The system acts as a bridge to heart transplantation for patients with end-stage heart failure.

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