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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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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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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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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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Catalyst Pharma Group (Pasadena, California) has entered into a strategic partnership with Spacelabs Medical Data (Issaquah, Washington).
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Implantable cardioverter defibrillator (ICD) implantation may contribute to a lower incidence of ventricular fibrillation (VF)-related out-of-hospital cardiac arrest treated by emergency medical services (EMS), according to a study published in the September issue of Heart Rhythm, a journal of the Heart Rhythm Society (formerly NASPE; Natick, Massachusetts).
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Abiomed (Danvers, Massachusetts) named Frank Menzler general manager for Abiomed BV, the company's European division. Menzler most recently was marketing manager for cardiac surgery for Guidant Europe and was a co-founder of Impella Cardiotechnik AG, a developer of minimally invasive blood pumps.
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Guidant (Indianapolis) said that the FDA has approved an expanded indication for the companys portfolio of cardiac resynchronization therapy defibrillators (CRT-D).
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Congestive heart failure (CHF) is a major and growing worldwide public health problem that is creating demands for a wide range of diagnostic, therapeutic and patient-monitoring technologies in Europe and most other developed regions.
