DANVERS, Mass., Aug. 2, 2013 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported that physicians have implanted more than 15,000 Impella® pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General Hospital in Sacramento, California with an Impella pump that provided prophylactic circulatory support.
Additionally, the higher flow Impella CP™ device, which received 510(k) clearance from the Food & Drug Administration in September 2012, has been implanted in more than 1,000 patients globally, after a roll-out to existing Impella 2.5 sites over the past 12 months. The 1,000th Impella CP procedure was performed at the Ochsner Medical Center in New Orleans, Louisiana.
"Impella has become an essential tool in our cath lab given its ease of use and ability to deliver minimally invasive hemodynamic support, for which there is a strong clinical need," said Michael Chang, M.D., the Regional Medical Director, Cardiovascular Services of Mercy Heart & Vascular Institute of Greater Sacramento, who performed the 15,000th Impella procedure. "We are excited to be a part of this Impella milestone and are proud of the clinical benefits we've been able to provide our patients."
"The Impella CP has great potential for treating patients in need of a percutaneously deployed hemodynamic support device," said Rajan Patel, M.D., FACC, of the John Ochsner Heart and Vascular Institute, who performed the 1,000th worldwide Impella CP procedure. "The ease of use and the level of hemodynamic support provided by the Impella CP make the device a valuable asset in the interventional cardiology toolbox."
The Impella platform, which is comprised of minimally invasive products with flow levels that vary with device size depending on the patient's need for hemodynamic support, includes the following:
In the U.S., the Impella 2.5, Impella CP and Impella 5.0 pumps have FDA 510(k) clearance for partial to full circulatory support for up to six hours.
"There is an increasing clinical need for hemodynamic support that is minimally invasive and allows for cost-effective treatment options," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "Today, we recognize that more than 15,000 American patients have received support from Impella, a clear sign that Impella is becoming the standard of care for percutaneous circulatory support. We are also gratified to see the strong physician acceptance of Impella CP, as evidenced by the 1,000th patient globally. I want to thank our physicians and hospital staff partners and the entire Abiomed team for contributing to this achievement."
Impella Key Facts:
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
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 the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, 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 most recently filed Annual 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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