Healthcare Industry News: RT Technology
News Release - July 18, 2007
Abiomed Announces Canadian Regulatory Approvals of Impella Circulatory Support TechnologiesFirst Impella Patient Treated in Toronto
DANVERS, Mass.--(HSMN NewsFeed)--Abiomed, Inc. (NASDAQ: ABMD ) today announced that the Company's ImpellaŽ 2.5 and ImpellaŽ 5.0 circulatory support technologies have been approved for use in Canada by Health Canada's Therapeutic Products Programme (TPP). In addition, the Company also announced that the first patients in Canada have received treatment with the Impella 2.5 technology at the Peter Munk Cardiac Centre at Toronto General Hospital.
"We are proud to be the first hospital in Canada to use this exciting new catheter-based circulatory suppoRT Technology for heart failure patients. We expect the Impella devices to be key treatment options for clinicians in our cath lab and surgical suites," said Vladimir Dzavik, BSc, MD, FRCPC, Director, Cardiac Cath Lab and Interventional Cardiology at the Peter Munk Cardiac Centre, Toronto General Hospital University Health Network.
The Impella 2.5 is a ventricular assist catheter, which is inserted percutaneously in the catheterization laboratory (cath lab) via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The Impella 2.5 can be inserted quickly and provides cardiovascular support for a high risk patient population while having their percutaneous coronary intervention (PCI), such as a stent or balloon angioplasty. It can also be used to provide additional blood flow to patients with low cardiac output, such as post-cardiotomy, or to protect the muscle of the heart following a heart attack. The device is currently available in Europe under the CE Mark. Abiomed recently announced that it has completed enrollment for the pilot study of the Impella 2.5 in the United States.
"Abiomed is focused on expanding the worldwide access to our heart recovery products through regulatory approval progress and we are pleased with this Canadian approval of our Impella platform. We look forward to working with Canadian cardiologists and surgeons to improve clinical outcomes for patients," said Michael R. Minogue, Chairman, CEO and President of Abiomed.
Abiomed's Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down or surgically. These pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion. The Impella 5.0 support systems are intended to be used for up to seven days as left ventricular cardiac assist devices. These technologies are currently available in Europe under the CE Mark and are in pilot studies in the United States under an Investigational Device Exemption (IDE).
Impella products are investigational devices limited by Federal Law solely to investigational use in the United States and are not currently available for sale in the United States.
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
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-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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