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Arrow International (Reading, Pennsylvania) said last month that it plans to defer a U.S. clinical trial of its current iteration of the LionHeart Left Ventricular Assist System (LVAS) for a destination therapy indication, saying it prefers to see how the next generation of the device, which has a smaller battery and other system enhancements, fares in the European market, where it was approved via a CE mark last November.
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Arrhythmia Research Technology (ART; Fitchburg, Massachusetts) said its wholly owned subsidiary, Micron Products, has completed the purchase of substantially all of the operating assets of privately held New England Molders (NEMI; Shrewsbury, Massachusetts).
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Alliance Medical (Phoenix, Arizona), a reprocessor of single-use medical devices (SUDs), said VHA (Irving, Texas), a cooperative of community-owned healthcare organizations, has renewed a three-year contract with Alliance.
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Gary Stickel has joined Abiomed (Danvers, Massachusetts) as vice president of human resources and development. Stickel previously was vice president of human resources at Segue Software. Abiomed is a manufacturer of devices designed to assist or replace the pumping function of the failing heart.
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The carotid artery stent system from Cordis Endovascular (Miami Lakes, Florida) is one step closer to approval by the FDA. At a meeting on April 21, the Circulatory System Devices Panel of the agencys Center for Devices and Radiological Health recommended approval of the premarket approval (PMA) application for the Cordis Carotid System, with conditions, by a narrow 6-to-5 vote.
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In patients with ALI/ARDS from pulmonary and extrapulmonary causes, receiving mechanical ventilation with low tidal volumes and high PEEP, short-term effects of recruitment maneuvers as conducted in this study are variable.
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Steroids Not Linked to Risk of Fractures; ADT Puts Men at Risk for Osteoporosis; Study Shows Valsartan May Improve Sexual Function in Postmenopausal Women; New Direct-to-Consumer Pharma Advertising Rules Considered; FDA Actions
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Drs. Stuart Connolly and Stefan Hohnloser presented results from the Defibrillator In Acute Myocardial Infarction Trial (DINAMIT). Prior studies had shown that patients with recent myocardial infarction and left ventricular dysfunction are at high risk for death in the period after myocardial infarction.
