Abiomed, Inc. (NASDAQ: ABMD) today announced regulatory approval in Australia for three of its Impella products. The Australian Register of Therapeutic Goods (ARTG) has approved the sale of Abiomed’s Impella LP 2.5 percutaneous left ventricular assist device, Impella LP 5.0 and Impella LD. The technology will be distributed in Australia through the distributor N. Stenning & Co. Pty. Ltd., Abiomed’s distributor for the AB5000 and BVS 5000 Circulatory Support Systems.
According to the National Heart Foundation of Australia, cardiovascular disease is the leading cause of death and disability in Australia with approximately 3.7 million Australians affected by cardiovascular disease.
“Abiomed’s focus on increasing our global distribution and regulatory approvals provides increased access to potentially lifesaving technologies,” said Michael R. Minogue, Chairman, CEO and President of Abiomed. “We are pleased to work with Australian clinicians and provide our Impella technologies to patients in acute heart failure, to help rest and potentially recover their native hearts.”
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 up to five days. The device is currently available in Europe under the CE Mark and is in pilot studies in the United States under an Investigational Device Exemption (IDE).
The Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down (Impella LP5.0) or surgically (Impella LD). 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 catheters 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 yet available for sale in the United States.
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® LP2.5, Impella® LP5.0, Impella® LD, the Impella® RD and an Intra-Aortic Balloon and the iPulse™ console 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 the Company’s 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.
