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Abiomed (Danvers, Massachusetts) last month submitted to the FDA an application for market approval of its AbioCor implantable replacement heart under a Humanitarian Device Exemption (HDE). Approval under an HDE would make the AbioCor commercially available to treat a defined subset of not more than 4,000 irreversible end-stage heart failure patients.
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Automated blood processing systems developer Haemonetics (Braintree, Massachusetts) reported that it has acquired all of the blood conservation technologies assets of Harvest Technologies (Plymouth, Massachusetts), a company that designs products intended to accelerate healing naturally, for roughly $4 million.
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CoreValve (Paris) will begin a European Phase I clinical trial of its ReValving System at The Heart Center (Seigburg, Germany), having received institutional review board (IRB) approval at that institution. The trial calls for use of the ReValving System to non-surgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery. The principal investigator will be Eberhard Grube, MD, chief of cardiology at The Heart Center.
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The Abbott Vascular Devices (Redwood City, California) division of Abbott Laboratories (Abbott Park, Illinois) reported in mid-September that it had enrolled the first patient in its ZOMAXX I drug-eluting coronary stent clinical trial. ZOMAXX I is a 400-patient, randomized clinical trial that will be conducted in more than 30 centers in Europe, Australia and New Zealand.
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Although headache is a common symptom in children and adolescents, only a very small percentage of patients present to the emergency department for evaluation of this complaint. The majority of these headaches are benign and are either primary, such as migraine or tension-type headaches, or secondary to a viral etiology. Parents and children themselves are most concerned about the possibility of a brain tumor, whereas ED physicians are also on the alert for carbon monoxide toxicity, subarachnoid hemorrhage, meningitis, and increased intracranial pressure. The authors review the causes, diagnostic testing, and treatment of the common headache, as well as some unusual causes of non-traumatic headache.
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Arranging care for uninsured and underinsured patients has become more complicated in the past four or five years, says Jennifer DeCamp, MSW, LSW, a social worker at Swedish Covenant Hospital in Chicago.
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The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has released its 2005 National Patient Safety Goals that will apply specifically to hospitals.
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Seton Northwest Hospital in Austin, TX, launched nearly 50 new quality initiatives in a single four-month period after deciding to participate in the Transforming Care at the Bedside (TCAB) program, which was launched by the Robert Wood Johnson Foundation (RWJF) in Princeton, NJ, and the Boston-based Institute for Healthcare Improvement (IHI).
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Hiring a case manager assigned specifically to manage joint replacement patients has paid dividends for St. Mary Medical Center in Langhorne, PA. The number of total hip and total knee surgeries has increased from 145 in fiscal year 2003 to an expected 260 during this fiscal year.
