W. L. Gore & Associates Inc. (Gore) announced the commercial availability of the Gore DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the United States, Europe, Canada and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures.

August 30, 2016 — Medtronic plc announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study at the 2016 European Society of Cardiology (ESC) Congress in Rome. The study showed that the Medtronic-exclusive device-based EffectivCRT during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF).

August 30, 2016 — Mission Health and GE Healthcare announced a novel, 10-year outcomes-based agreement that will help drive significant value for patients, Mission Health, GE and health systems nationwide.

Siemens Healthineers announced that the U.S. Food and Drug Administration (FDA) has cleared the Somatom Drive computed tomography (CT) system. This new dual-source scanner is designed to drive precision in diagnostic imaging across a wide range of clinical disciplines, from pediatrics and emergency medicine to cardiology and oncology. The system has the potential to reduce examination time, preparation and follow-up care.

August 29, 2016 — Medtronic plc announced new long-term results from the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial in a late-breaking session at the 2016 European Society of Cardiology (ESC) Congress. The meeting runs from Aug.27-31 in Rome.

Cybersecurity concerns were raised over the St. Jude Medical (SJM) Merlin@home EP device home monitoring system

August 29, 2016 — Investment research firm Muddy Waters Capital released a report Aug. 25 saying it believes St. Jude Medical (SJM) will lose up to half of its revenue due to what it calls issues with its electrophysiology (EP) devices, including pacemakers, implantable cardioverter defibrillators (IDCs) and cardiac resynchonization therapy (CRT) devices.

This week, PinnacleHealth, Harrisburg, Pa., became the first hospital in the country to implant the Edwards Intuity Elite valve, a rapid deployment device for surgical aortic valve replacement, after U.S. Food and Drug Administration (FDA) approval.

August 26, 2016 — As a further safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

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