Technology | Dave Fornell

The U.S. Food and Drug Administration (FDA) has granted approval of Medtronic’s premarket approval application (PMA) for the Melody Transcatheter Pulmonary Valve (TPV) and its Ensemble Transcatheter Valve Delivery System. This allows wider use of the valve in patients born with congenital heart defects that often require multiple open-heart surgeries. The valve is designed to reduce the number of open surgeries and expand the time between them.

Home January 28, 2015
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NewYork-Presbyterian Hospital/Columbia University Medical Center is one of a select group of medical centers participating in a clinical trial of a new device for advanced heart failure patients, the Thoratec HeartMate III Left Ventricular Assist System (LVAS).

Home January 27, 2015
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ECRI Institute has released an updated comparison on cardiac resuscitators used during cardiopulmonary resuscitation (CPR).

Home January 27, 2015
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HHS, Medicare, payment, fee-for-service, alternative models, business
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Health and Human Services Secretary Sylvia M. Burwell announced measurable goals and a timeline to move the Medicare program and the healthcare system at large toward paying providers based on the quality, rather than the quantity of care they give patients. The announcement was made in a meeting with nearly two dozen leaders representing consumers, insurers, providers and business leaders.

Home January 27, 2015
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3-D printing, tracheal reconstruction, STS, Goldstein, Feinstein Institute
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Three-dimensional (3-D) printing can effectively create a biodegradable tracheal segment containing a patient’s own cells for use in complex tracheal reconstruction, according to a proof of concept study abstract released at the 51st Annual Meeting of The Society of Thoracic Surgeons.

Home January 27, 2015
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CytoSorbents Corporation announced that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to conduct its proposed clinical trial using CytoSorb intra-operatively in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine.

Home January 27, 2015
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Ortho-Clinical Diagnostics Inc. announced the nationwide availability to hospitals of the Nephrocheck Test System designed to help healthcare providers identify patients at risk of developing moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment.

Home January 27, 2015
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FEops announced the closing of a €1.3 million (~$1.9 million USD) series A financing round, led by Capricorn Venture Partners and PMV. The funding will be used to support the launch of FEops’ first product, TAVIguide, in key markets in Europe and the United States.

Home January 26, 2015
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clinical trial/study, imaging, CT imaging
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According to a study published online in the Journal of the American College of Radiology (JACR), large majorities of primary care physicians believe that advanced medical imaging, such as computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) provides considerable value to patient care.

Home January 26, 2015
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clinical trial/study, stem cell therapies, BHF
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The British Heart Foundation (BHF) announced the winners of its annual ‘Reflections of Research’ image competition – reflecting the charity’s research into heart and circulatory diseases.

Home January 26, 2015
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CardioKinetix Inc. announced the completion of enrollment in Parachute China, a multi-center trial to evaluate the minimally invasive Parachute Ventricular Partitioning Device for the treatment of heart failure.

Home January 23, 2015
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Technology

Kopp Development Inc. released a new entryway system — FerrAlert Halo II Plus.

Home January 23, 2015
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St. Jude Medical Inc. announced the first patient enrollment in the STAR-VT (Substrate Targeted Ablation using the FlexAbility Ablation Catheter System for the Reduction of VentricularTachycardia) clinical trial, a prospective, multi-center, randomized study evaluating the safety and efficacy of the FlexAbility ablation catheter in ventricular tachycardia (VT) ablation procedures.

Home January 22, 2015
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Cleveland HeartLab (CHL) announced that it has acquired the MIRISK cardiovascular disease (CVD) risk assessment tool. Developed at Stanford University School of Medicine and validated in an eight-year, 5,000-patient clinical study, MIRISK is a highly accurate tool for determining a patient's potential long-term risk of a heart attack.

Home January 22, 2015
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AstraZeneca announced that the PEGASUS-TIMI 54 study, a large-scale outcomes trial involving more than 21,000 patients, successfully met its primary efficacy endpoint. The study assessed ticagrelor (Brilinta) tablets at either 60 mg twice daily or 90 mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke.

Home January 22, 2015
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