DANVERS, Mass., June 3, 2014 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported that physicians have implanted more than 20,000 Impella® pumps in U.S. patients requiring hemodynamic support. The 20,000th Impella procedure took place at Keck Medicine of University of Southern California (USC) hospital. To date, the higher flow Impella CP® has been implanted in over 3,000 U.S. patients, with the 3,000th procedure taking place at Hoag Memorial Hospital Presbyterian.
"We are pleased with the higher support offered by the Impella CP and have found this device to be a staple in our program for critically ill patients who need consistently improved hemodynamic support," said Subbarao Myla, M.D., Medical Director of Cardiovascular Catheterization Laboratories at Hoag Heart and Vascular Institute at Hoag Memorial Hospital Presbyterian.
"With the Impella platform integrated into our program, we are able to offer the sickest patients the full spectrum of hemodynamic support with minimally invasive procedures," said Ray Matthews, M.D., Director of Department of Interventional Cardiology at University of Southern California (USC), who performed the 20,000th Impella procedure. "Impella has become a necessary tool in our cath lab and we are excited to be part of this important milestone for the clinical community."
The Impella platform consists of the Impella® 2.5, Impella® CP and Impella® 5.0, which all currently have Food & Drug Administration (FDA) 510(k) clearance for partial to full circulatory support for up to six hours. Completing the Impella platform to offer the full spectrum of hemodynamic support are the Impella® RP (Right Peripheral), which is limited by federal law to investigational use and the use of Impella in the pediatric population, which will be submitted for an IDE this year.
The Impella RP recently received CE Marking approval in the European Union (EU) and also completed patient enrollment in its Investigational Device Exemption (IDE) trial, RECOVER RIGHT, with an extended Continuous Access Protocol (CAP) to allow the Company to continue enrolling an additional 22 patients into the trial for further evaluation. FDA approval for the Impella RP is expected by early 2015.
"As the population becomes older and sicker than ever before, we believe that the Impella platform will become the standard of care for biventricular percutaneous circulatory support," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed.
The Impella 2.5 is currently in the FDA 515 process. The data for the Impella 2.5 Pre-Market Approval (PMA) submission was sent to the FDA last quarter. The totality of data contained in the PMA submission includes clinical data from 215 publications, references to 1,638 Impella 2.5 patients, including three FDA studies: PROTECT I, PROTECT II and RECOVER I, as well as 791 new high risk Impella patients from the U.S. Impella registry. The PMA package contained thousands of pages of documents which represent more than eight years of clinical research with an investment of greater than $35 million.
Hemodynamic support with Impella is now included in five sets of clinical practice guidelines:
1. 2011 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/ Society for Coronary Angiography Interventions (SCAI) for percutaneous coronary intervention;
2. 2012 ACC/AHA Guidelines for Management of ST-Elevation Myocardial Infarction (STEMI);
3. 2012 AHA Recommendations for the Use of Mechanical Circulatory Support: Device Strategies & Patient Selection;
4. 2013 International Society for Heart & Lung Transplantation (ISHLT) guidelines for Mechanical Circulatory Support
5. 2013 ACCF/AHA Guidelines for the Management of Heart Failure.
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 and 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.
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