Healthcare Industry News: Impella
News Release - July 17, 2006
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 DeviceDANVERS, Mass.--(HSMN NewsFeed)--July 17, 2006--Abiomed, Inc. (NASDAQ: ABMD ) today announced the start of the Impella® 2.5 pilot study in the United States with the enrollment of the first patient at William Beaumont Hospital in the Detroit area. The Impella 2.5 is the world's smallest ventricular assist device (VAD) 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 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 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 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 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. 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® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, Abiomed offers the Impella® RECOVER® minimally invasive cardiovascular support systems under CE Mark approval. The Impella® 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® Implantable Replacement Heart was the subject of an initial clinical trial under an Investigational Device Exemption from the United States Food and Drug Administration. 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.
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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.
Source: Abiomed
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