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Edwards Lifesciences received conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards Sapien 3 transcatheter aortic heart valve and accessories.

Home August 06, 2013
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August 5, 2013 — AstraZeneca announced results from a new sub-analysis of the PLATO study that evaluated the incidence of stent thrombosis in patients with acute coronary syndrome (ACS).

Home August 05, 2013
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Thubrikar Aortic Valve’s Optimum TAV, transcatheter aortic valve implantation (TAVI) system, has surpassed 200 million cycles in an ongoing durability test — which simulates over five years in humans and meets the requirement set by the International Organization for Standardization (ISO) — in a third party GLP study.

Home August 05, 2013
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Abiomed Inc. reported that physicians have implanted more than 15,000 Impella pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General Hospital in Sacramento, Calif., with an Impella pump that provided prophylactic circulatory support.

Home August 05, 2013
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Technology

The U.S. Food and Drug Administration (FDA) recently granted market clearance for a hand lotion designed to offer radiation protection from X-rays. Physicians such as interventional cardiologists who work with live angiographic fluoroscopic X-ray systems often have their hands in the radiation field during imaging. The cream, developed by radiation protection product company BloXR Corp., is applied prior to donning gloves, or over a glove with another glove on top, to serve as a lightweight radiation shield

Home August 02, 2013
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Abbott announced results from a study evaluating its High Sensitive Troponin-I (hsTnI) assay. The study, conducted by researchers at Brigham and Women's Hospital, demonstrated that Abbott's hsTnI test (currently for research-use only in the United States) may help doctors predict which patients presenting with symptoms of a heart attack, such as severe chest pain, are at a higher risk for having a heart attack 30 days later.

Home August 02, 2013
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Mercator MedSystems has been issued U.S. Patent 8,465,752, which protects the company’s sole U.S. rights to deliver drugs or other nerve modifying agents to tissue surrounding arteries for renal denervation (RDN). The system also can be used for carotid body modulation (CBM) procedures.

Home August 02, 2013
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InspireMD Inc. said the first patient has been enrolled in the Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard Prime Embolic Protection Stent (EPS) in patients suffering from ST elevation myocardial infarction (STEMI).

Home August 01, 2013
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Technology

The Mikro-Cath disposable blood pressure catheter delivers accurate and reliable hemodynamic data from within the heart or vascular system for expert insight in advanced applications.

Home August 01, 2013
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August 1, 2013 — Boston Scientific Corp. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rhythmia mapping system, a next-generation 3-D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology (EP) procedures to diagnose or treat a variety of conditions in which the heart beats abnormally.

Home August 01, 2013
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Magnetic resonance imaging (MRI) scans of children who have had chemotherapy can detect early changes in their hearts, according to research findings in BioMed Central's open access journal Journal of Cardiovascular Magnetic Resonance.

Home July 31, 2013
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Technology

Polymer Technology Systems Inc. has introduced the CardioChek Plus analyzer. It is a combination reflectance lipid and electrochemical glucose analyzer that delivers rapid test results for lipids and glucose simultaneously. The system has Wi-Fi capabilities and can transmit patient results to data collection applications.

Home July 31, 2013
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Feature | Gavin Hays, CEO, Springboard Inc.

The healthcare sector in the United States is facing several reforms, mainly from the implementation of the Patient Protection and Affordable Care Act. However, the results from a survey of 1,710 cath lab clinicians projected a positive outlook for participating clinical professionals with the majority of the respondents reporting higher wages and more than three quarters of the respondents expecting to receive annual salary increases. This indicates that the trend toward higher wages will continue going forward.

Home July 30, 2013
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MEDTRONIC, symplicity renal denervation catheter
Feature | Dave Fornell

One of the exciting new frontiers for interventional cardiology is the use of renal denervation therapy to treat pharmacologically uncontrolled hypertension. It is estimated there are more than 10 million drug-resistant hypertension patients in the United States, so renal denervation (RDN) may offer a massive new market for cath labs to tap into.

Home July 30, 2013
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Technology

Nick Cavros, interventional cardiologist with Cardiovascular Institute of the South (CIS) at Lafayette General Medical Center in Lafayette, La., used a new hand-held mechanical aspiration system to remove blood clots and increase blood flow.

Home July 30, 2013
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