Healthcare Industry News: Impella
News Release - May 22, 2006
ABIOMED Announces French Regulatory Approval of the AB5000 Circulatory Support System
ABIOMED to Open French Office for Direct Sales and Clinical Support for CustomersDANVERS, Mass. and AACHEN, Germany--(HSMN NewsFeed)--May 22, 2006--ABIOMED, Inc. (NASDAQ: ABMD ) today announced that the French regulatory agency for medical devices, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has granted approval of the AB5000(TM) Circulatory Support System. France represents one of the largest medical device markets in Europe. All of ABIOMED's Circulatory Support Systems including the Impella products are now available in France, providing French patients in acute heart failure with access to life-saving circulatory support. In addition, ABIOMED announced plans to open an office in Paris to provide French customers with direct customer service, and sales and clinical expertise as they incorporate Ventricular Assist Device (VAD) Recovery Programs into standard clinical practice.
The AB5000 is a VAD that was designed to rest and recover a patient's heart following such events as cardiogenic shock resulting from myocardial infarction, myocarditis, postpartum cardiomyopathy, ventricular septal defect, refractory arrhythmias, failed heart transplants, right ventricular assistance with implantable LVAD (Left Ventricular Assist Device), and postcardiotomy cardiogenic shock (PCCS). The ABIOMED® AB5000(TM) System also allows patients to walk with the support of the console.
"We are excited by the momentum in Europe overall and also with this new access to the French market," stated Michael R. Minogue, Chairman, President and CEO of ABIOMED. "The U.S. clinical data supporting heart recovery using our technology is extensive and we are seeing increased utilization worldwide. Our plan for a new office in France demonstrates our strong commitment to work closely with our customers and clinical leaders in France to assist in the development of Recovery Programs for their patients."
ABIOMED has exclusive labeling in the United States for recovery indications through its AB5000 and BVS 5000 platforms. The Company's global sales and clinical teams now total more than 45 individuals and the Company announced recently its intention to hire 2-4 additional sales and clinical professionals globally per quarter in fiscal 2007.
ABOUT THE AB5000(TM) Circulatory Support System
The AB5000 was FDA approved in September 2003 to provide temporary support for one or both sides of the natural heart in circumstances where the heart has failed, giving the patient's heart the opportunity to rest and potentially recover - and giving surgeons the therapeutic flexibility necessary to determine the best endpoint for treatment. The AB5000 and the BVS 5000 are the only devices with recovery labeling in the United States.
The AB5000(TM) Ventricle, a major component of the AB5000 Circulatory Support System, is a pneumatically driven blood pump. The sterile, disposable Ventricle provides circulatory support in the presence of left-, right-, or both-sided heart failure. The Ventricle is located next to the body (paracorporeal) and can take over the pumping function of the natural heart. Assisted by vacuum, blood flows from the native heart into the AB5000 Ventricle bladder. The bladder, which holds about 100 cc of blood, fills and empties much like the natural heart. Connection of the Ventricle to the patient is accomplished by connecting the pump to cannulae, or tubes, implanted in the patient's heart. These tubes pass through the patient's skin and connect directly to the AB5000(TM) Console.
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 products 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.
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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