Technology

November 11, 2011 — Maquet Cardiovascular announced U.S. Food and Drug Administration (FDA) 510(k) clearance and CE mark for its new Cardiosave intra-aortic balloon pump (IABP). The announcement came at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco. The system is expected to be commercially available in the United States in January 2012.

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November 11, 2011 – Boston Scientific reported results from the EVOLVE first human use trial demonstrating the non-inferiority of the Synergy everolimus-eluting stent system compared to the Promus Element everolimus-eluting stent system in treating de novo coronary artery lesions. The trial provided 30-day clinical and six-month angiographic primary endpoint data evaluating the safety and effectiveness of the bioabsorbable polymer-coated Synergy stent. Results were presented today during a late-breaking clinical session by professor Ian T. Meredith, M.B.B.S., Ph.D., director of MonashHeart, Monash Medical Centre, Melbourne, Australia, and principal investigator of the trial, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.

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November 11, 2011 – Biosensors International Group announced two-year results from the BioFreedom first-in-human trial, which showed similar clinical outcomes between BioFreedom, a polymer-free, drug-coated stent (DCS), and Boston Scientific’s Taxus Liberté drug-eluting stent (DES). There was no evidence of stent thrombosis in either trial arm. Results were presented by Professor Eberhard Grube, University Hospital Bonn, Germany, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

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November 11, 2011 — The 30-day results from the 8,500+ patient ADAPT-DES registry were presented at the 2011 TCT conference in San Francisco. Patients with high platelet reactivity, as measured by the Accumetrics VerifyNow P2Y12 test, exhibited an approximately four times higher rate of stent thrombosis than patients without high platelet reactivity.

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November 10, 2011 — The results of an analysis of 149 EVEREST II high surgical risk patients with significant mitral regurgitation (MR) of functional etiology were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2011. Michael Argenizano, M.D., chief of adult cardiac surgery for New York-Presbyterian Hospital/Columbia University Medical Center made the presentation.

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November 10, 2011 — Edwards Lifesciences Corp. announced the U.S. Food and Drug Administration (FDA) conditionally approved the addition of a second treatment group to the PARTNER II Trial. The trial is studying the company's next-generation Edwards Sapien XT transcatheter heart valve.

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November 10, 2011 – GE Healthcare will feature several new products and solutions at the Cardiovascular Research Foundation’s 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

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November 9, 2011 — InfraReDx Inc. announced the launch of its TVC Imaging System, an enhanced version of the LipiScan IVUS coronary imaging system.

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November 9, 2011 — Currently under review by the U.S. Food and Drug Administration (FDA), the Resolute drug-eluting stent (DES) from Medtronic Inc. continues to demonstrate consistently positive performance across a variety of studies. These conclusions come from two new data analyses being presented this week at Transcatheter Cardiovascular Therapeutics (TCT) 2011.

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November 9, 2011 – AstraZeneca announced that a combined expert committee of American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI) has updated its guidelines for the management of patients undergoing percutaneous coronary intervention (PCI) to provide a Class I recommendation for giving the oral antiplatelet medicine, Brilinta (ticagrelor) tablets for patients undergoing PCI.

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November 9, 2011 — Volcano Corp. announced results from the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) clinical trial will be presented in a Late-Breaking Session at Transcatheter Cardiovascular Therapeutics (TCT) 2011. The event is taking place from Nov. 7-11 in San Francisco.

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November 9, 2011 – Abiomed, a provider of heart support technologies, announced results of an economic study at the annual 2011 Transcatheter Cardiovascular Therapeutics (TCT) conference. The economic study demonstrated that Impella significantly reduced major adverse events at an incremental cost per quality-adjusted life year considered to be cost-effective for advanced cardiovascular technologies. Quality of life benefits included an increase in ejection fraction of over 20 percent and an improvement in New York Heart Association (NYHA) Class III and Class IV heart failure of over 50 percent.

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November 9, 2011 — Janssen Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has approved Xarelto to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AFib). Xarelto is an oral anticoagulant that offers once-daily dosing without the need for routine blood monitoring.

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November 9, 2011 – Siemens Healthcare announced that the company has entered into a definitive agreement to acquire all issued and outstanding equity of MobileMD Inc., of Yardley, Pa., a provider of health information exchange (HIE) solutions.

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November 9, 2011 – A group of states and vendors focused on eliminating the barriers to sharing electronic health records (EHRs) issued a set of technical specifications to standardize connections between healthcare providers, health information exchanges (HIEs) and other data-sharing partners.

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