Journal Of The American College Of Cardiology Publishes PROTECT I Study Results For Abiomed Impella 2.5

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 13 Mar 2009 - 6:00 PDT

email to a friend   printer friendly   view / write opinions

Results from the PROTECT I trial evaluating the feasibility and effectiveness of the Abiomed, Inc. (NASDAQ: ABMD) Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention (PCI) procedures have been published in the February issue of the Journal of the American College of Cardiology (JACC). The study, "A Prospective Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (The PROTECT I Trial)¹" concludes that "The Impella 2.5 system is safe, easy to use, and provides excellent hemodynamic support during high-risk PCI [percutaneous coronary intervention]."

The PROTECT I trial enrolled 20 patients undergoing high-risk PCI at seven centers between July 2006 and April 2007. Eligible patients had left ventricular ejection fraction (EF) of less than 35% and were required to undergo PCI on either an unprotected left main coronary artery or the last patent coronary conduit.

"The Impella 2.5 is poised to change the standard of care in our efforts to combat heart disease and its devastating after-effects," said Igor F. Palacios, MD, Director of Interventional Cardiology, Massachusetts General Hospital, Boston, Mass., Associate Professor of Medicine at Harvard University Medical School and participating cardiologist in the Protect I trial. "The PROTECT I trial enrolled a very sick patient population and demonstrated that the device works and validated its impressive safety profile, showing no valve, blood or vascular damage, no instances of stroke and a low adverse event rate."

Hospitals enrolling patients included Academic Medical Center, Brigham and Women's Hospital, Cedars Sinai, Massachusetts General Hospital, Scripps Clinic, Texas Heart Institute and William Beaumont Hospital. William W. O'Neill, MD, Professor and Executive Dean for Clinical Affairs at the Leonard M. Miller School of Medicine, University of Miami was the Principal Investigator for the study.

The Impella 2.5 received 510(k) clearance from the FDA in June 2008 for partial circulatory support for periods up to six hours. It is inserted percutaneously in the catheterization lab (cath lab) via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute is delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. Now approved in more than 40 countries, including in Europe under the CE Mark, Impella 2.5 has been used to treat over 1,700 patients worldwide and has been the subject of more than 50 peer-reviewed publications.

"We are pleased that the PROTECT I Study provided evidence for the safety, efficacy and ease of use of the Impella 2.5," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "For Abiomed, measuring mortality is just the first step. We believe that saving heart muscle is the key to recovering patients' hearts, improving treatment and ultimately, making Impella the standard of care."

Abiomed is also currently conducting two U.S. pivotal studies comparing the Impella 2.5 to the IABP (Protect II for high-risk percutaneous coronary intervention, or PCI; and Recover II for acute myocardial infarction, AMI or heart attack). There are an estimated 60,000 annual high-risk PCI patients and 100,000 AMI anterior infarct patients annually in the United States.

The study may be accessed online at http://interventions.onlinejacc.org/cgi/content/full/2/2/91.

1. "A Prospective Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (The PROTECT I Trial)," (J. Am. Coll. Cardiol. Intv. 2009; 2; 91-96).

About Abiomed

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: http://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 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.

Abiomed