Abiomed, Inc. (NASDAQ: ABMD) today announced that its Impella® 2.5 Circulatory Support System has been awarded a 2007 Medical Design Excellence Award (MDEA). The award recognizes groundbreaking innovations and achievements that are changing the face of healthcare.
The Impella 2.5 is a Ventricular Assist Device designed to pump up to 2.5 liters of blood per minute, supporting the heart in situations when it cannot function on its own. Available in Europe under CE Mark approval and currently in pilot clinical trial studies in the U.S. under an Investigational Device Exemption (IDE), the Impella 2.5 was recognized in the critical-care and emergency medicine products category for its product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.
“The Impella 2.5 technology was engineered to provide significant blood flow to cath lab patients. This award recognizes our research and development teams, who created a device that can save lives and help recover patients’ hearts,” said Michael R. Minogue, Chairman, CEO and President of Abiomed.
The Impella 2.5 provides patients with sustained coronary perfusion when their hearts are unable to do so. The device is small and is designed to be inserted percutaneously by interventional cardiologists in the cath lab. The Impella 2.5 can be quickly inserted into the left ventricle via a standard guidewire through the femoral artery, into the ascending aorta, across the valve and into the left ventricle. It can remain in place for up to five days.
Presentation of the 2007 MDEA awards will take place on Wednesday, June 13, in a ceremony at the Medical Design & Manufacturing (MD&M) East 2007 Conference and Exposition, in New York City. To learn more about the Impella 2.5 visit www.abiomed.com.
Impella products are investigational devices limited by Federal Law solely to investigational use in the United States and are not yet available for sale in the United States.
ABOUT MDEA
MDEA is the premier awards program for the medical technology community. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA entries are judged on the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery. A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics.
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™ Circulatory Support System and the BVS® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor® Implantable Replacement Heart. In Europe, Abiomed offers the Impella® 2.5, Impella® 5.0, Impella® LD, the Impella® RD and an Intra-Aortic Balloon 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 and the iPulse™ combination console system are not yet available for sale in the United States. 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 its most recently filed quarterly report on Form 10-Q. 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.
