Abiomed Announces Patient Enrollment in Impella 2.5 Pilot Trial; First U.S. Patient Successfully Treated for High-Risk Angioplasty with World's Smallest Ventricular Assist Device.DANVERS, Mass. -- Abiomed, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ABMD ABMD areal bone mineral density ABMD AEGIS Ballistic Missile Defense (US Navy) ABMD Advanced Ballistic Missile Defense ) today announced the start of the IMPELLA(R) 2.5 pilot study in the United States with the enrollment of the first patient at William Beaumont Hospital This article is about William Beaumont Hospital, Michigan. For for the hospital in Dublin, see Beaumont Hospital, Dublin. William Beaumont Hospital is a regional medical system in the greater Detroit, Michigan area. in the Detroit area. The IMPELLA 2.5 is the world's smallest ventricular assist device ventricular assist device: see under heart, artificial. (VAD (Value Added Dealer) Same as VAR. ) and is currently available in Europe under the CE Mark. The treatment involved utilizing Abiomed's IMPELLA 2.5 minimally invasive ventricular assist device during high-risk angioplasty, and provided strong hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he support with over 2 liters of flow for the patient throughout the procedure. It is estimated that 5 to 10 percent of the one million U.S. angioplasty cases are considered high-risk. In this case, the patient had previously received a bypass, a defibrillator, had poor heart function and needed angioplasty to open a complex lesion in the vessel supplying blood to the heart itself. The IMPELLA 2.5 was implanted quickly and easily through the groin, and resulted in a favorable procedural outcome for the patient who has already been discharged from the hospital, approximately 48 hours after the procedure. "The IMPELLA 2.5 technology is revolutionary and one of the most exciting new products I have seen in interventional cardiology," stated William O'Neill, Corporate Director of Cardiology, William Beaumont Hospital System. "The ease of insertion of IMPELLA and its unique capability to unload the left ventricle and enhance flow to the body improved the patient safety during this complex, high-risk angioplasty procedure performed by Dr. Simon Dixon." "The device is very easy to use in the catheterization catheterization Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. lab environment," said Dr. Dixon. "It helps optimize the treatment of very challenging lesions for the benefit of the patient." "We believe IMPELLA 2.5 will change the standard of care in cath labs worldwide, and are pleased by the positive results from the first patient procedure in the U.S.," stated Michael R. Minogue, Chairman, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Abiomed. Abiomed announced that it will conduct a conference call in the future to outline the further details of the trial. On May 25, 2006, the Company announced that it had received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval to commence its pilot clinical trial in the United States for the IMPELLA 2.5 minimally invasive ventricular assist device. The indication for use is support during high-risk angioplasty and subsequent to the procedure, if needed, for up to five days as a left ventricular assist device left ventricular assist device Cardiology A mechanical device to ↑ force and volume of blood flowing through the heart. Cf CABG, Jarvik-7. . Angioplasty, performed in the catheterization lab, is the insertion of a catheter-guided balloon and is used to open a narrowed coronary artery. A stent (a wire-mesh tube that expands to hold the artery open) is usually placed at the narrowed section. High-risk angioplasty is defined as patients undergoing angioplasty on an unprotected left main coronary artery lesion, or the last patent coronary conduit, and poor cardiac function. ABOUT ABIOMED Based in Danvers, Massachusetts, Abiomed, Inc. is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. Abiomed currently manufactures and sells the AB5000(TM) Circulatory Support System and the BVS BVS Biblioteca Virtual em Saúde (Brazil) BVS Bureau of Vital Statistics BVS Brethren Volunteer Service (Church of the Brethren) BVS Boston Vegetarian Society (Cambridge, MA) (R) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, Abiomed offers the IMPELLA(R) RECOVER(R) minimally invasive cardiovascular support systems under CE Mark approval. The IMPELLA(R) 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other IMPELLA devices are not yet available for sale in the United States. The Company's AbioCor(R) Implantable Replacement Heart was the subject of an initial clinical trial under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. For additional information please visit: www.abiomed.com. Contacts: FORWARD-LOOKING STATEMENTS This Release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events. |
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