Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/minDANVERS, Mass., Sept. 10, 2012 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella® device providing peak flows of approximately four liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP™ (Cardiac Power) within the United States and has been commercially known outside the U.S. as the Impella cVAD™.
"The clinical community has been anxiously anticipating the arrival of this new Impella pump. The Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support," said John Lasala M.D., medical director of Washington University School of Medicine in St. Louis. "It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80% of what a healthy heart can pump each minute."
"We are very pleased to announce the availability of the new Impella CP and we expect this to be a significant tool in helping more patients," said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. "The addition of the Impella CP to the growing Abiomed product portfolio further emphasizes the company's commitment to innovation and our dedication to patients."
This 510(k) clearance designates that the Impella CP has the same indications for use1 as the Impella 2.5 and includes a limitation in the Impella CP instructions for use (IFU)2. In April 2012, Abiomed received CE Marking approval to market the Impella cVAD in the European Union3. Abiomed plans to have a controlled launch with top heart hospitals in the United States, with full U.S. commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013.
Abiomed has three FDA studies (PROTECT I, RECOVER I, PROTECT II) that are now published on Impella, and there are also over 150 peer reviewed publications including real world usage data from the Europe and U.S. Impella registries. Additionally, Impella has been utilized to support over 10,000 U.S. patients, has been incorporated into the medical guidelines and has recently been approved for a dedicated CPT code for physician payment.
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1. Indication: The Impella CP is "intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass."
2. For Impella CP only: "The safety and effectiveness of this device has not been established for use in providing partial or full support of the blood circulation for periods of greater than six hours, or for providing prophylactic hemodynamic support, for example, in patients with stable hemodynamics during percutaneous interventional procedures of high risk coronary artery lesions and/or anatomy."
3. Upon CE Marking approval, Abiomed partnered with nine key opinion leaders and institutions in the European Union to conduct a limited market release. This successful market evaluation validated the performance and ease of use of the new Impella pump, introducer, and Automated Impella Controller (AIC) operating software.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. 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 and expected regulatory approvals. 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, including 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 and 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.
