October 25, 2007
Abiomed Announces Results of Impella(R) 2.5 FDA PROTECT I Safety Trial for High-Risk PCI Cases
Abiomed, Inc. (NASDAQ: ABMD) formally announced the results of its ImpellaÃ® 2.5 PROTECT I safety trial for the first time at the Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium and main sessions.
PROTECT I is the first prospective multi-center, FDA-approved trial for prophylactic, or preventative, use of a device during high-risk percutaneous coronary intervention (PCI) procedures. The 20 patient pilot study with the Impella 2.5 met all primary and secondary endpoints and showed very low adverse event rates in a very sick patient population. The results demonstrated no incidents of: aortic valve damage, aortic or mitral dysfunction, sepsis, stroke, thromboembolic events, vascular complications, insertion-site infection, device malfunction, device-related bleeding, limb ischemia, or clinical issues with hemolysis.
"We are pleased to release the successful results of the safety trial at TCT and are excited to begin the pivotal study with an expanded patient population including high-risk PCI with triple vessel disease for patients at up to 150 centers," said Michael R. Minogue, Chairman, CEO and President of Abiomed. "Experience with the Impella 2.5 in the safety trial and in multiple studies in Europe under CE-Mark provides significant evidence of the clinical benefit to patients, and we continue to work with the FDA to bring this breakthrough technology to the U.S."
"In the PROTECT I pilot trial, Impella delivered supreme protection and support. It enabled success in procedures that would have been otherwise impossible," said Dr. J.P.S. Henriques, Cardiologist at the Academic Medical Center in Amsterdam.
Dr. Laura Mauri of Brigham & Women's Hospital also presented new data from the completed PROTECT I trial: "Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk PCI." An independent Core Lab analysis completed at Duke University determined no damage to the septum, heart chambers, or mitral/aortic valves. At a 30-day follow-up, patients enrolled in the PROTECT I trial showed an improvement of their heart function demonstrated by an absolute increase of 7% in their left ventricular ejection fraction, equating to a 27% relative increase.
"We have been impressed by the ease-of-use and high safety profile of the Impella 2.5 technology during the PROTECT I pilot trial," said Dr. William O'Neill, National Principal Investigator for the pilot and pivotal studies of the Impella 2.5, and Professor and Executive Dean for Clinical Affairs, Division of Cardiology at the Leonard M. Miller School of Medicine at the University of Miami. "With an aging population, Impella will have a significant role in the treatment of high-risk patients, so we are excited to further demonstrate its effectiveness in the recently approved pivotal trial."
Participants from world class centers and investigators for the Impella 2.5 safety trial included: Dr. William O'Neill, Principal Investigator, University of Miami; Dr. Magnus Ohman, Independent Medical Monitor, Duke University; Dr. Simon R. Dixon, William Beaumont Hospital, MI; Dr. Frederic Resnic and Dr. Laura Mauri, Brigham & Women's Hospital, MA; Dr. Igor Palacios, Mass General Hospital, MA; Dr. Andrew Civitello, Texas Heart Institute, TX; Dr. J.P.S. Henriques, Academic Medical Center, Amsterdam, NL; Dr. Paul Teirstein, Scripps Clinic, CA;, NY; and Dr. Michael Collins, New York-Presbyterian Hospital.
Also announced for the first time at TCT was Abiomed's new percutaneous right side catheter that can deliver greater than 4 liters of flow. This product will provide key support to the failing right ventricle and will be introduced first in Europe. More information will be provided in the future.
Other Abiomed presentations at TCT included:
"Recovery of Left Ventricular Function in Cardiogenic Shock after Temporary LVAD Implantation," a surgeon's perspective with AB5000 and the Impella 5.0, Dr. Mark B. Anderson, Chief of the Section of Cardiac Surgery, Robert Wood Johnson University Hospital "Impella: Safety and Clinical Utility of a Temporary Transaortic Forward Flow Hemodynamic Support Device," Dr. Simon R. Dixon, William Beaumont Hospital, Royal Oak
"AbioCor Implantable Replacement Heart: Indications, Complications, and the Clinical Role," Dr. Robert D. Dowling, Professor of Surgery at the University of Louisville School of Medicine and Jewish Hospital
"Future Perspectives of Circulatory Support in Acute Heart Failure: Rationale for a Continuum of Care," Dr. Eberhard Grube, Chief, Department of Cardiology and Angiology, HELIOS Heart Center, Sieburg, Germany
"Protecting the Heart Under Stress During High Risk Interventions: How Far Can We Push The Limit?," Dr. Frederic Resnic, Medical Director, Cardiac Catheterization Laboratory, Brigham and Women's Hospital
"Recovering the Dysfunctional Heart: Is it Time for a Paradigm Shift in Management of ACS?," Dr. J.P.S. Henriques, Department of Cardiology, Academic Medical Centre, University of Amsterdam, Netherlands
"Bridging the Gap Between Cardiology and Surgery: What Makes Sense for Our Patients?," Dr. Magnus Ohman, Director, Program for Advanced Coronary Disease Division of Cardiology, Duke University
"Recovering the Failing Heart in Profound Shock Conditions: Surgical VAD Improves Outcomes," Dr. Mark B. Anderson, Chief of the Section of Cardiac Surgery, Robert Wood Johnson University Hospital
"Late-Breaking Clinical Trials with Minimally Invasive Circulatory Support Technology: IMPRESS, PROTECT and RECOVER, what does it all mean?," Dr. William O'Neill, Executive Dean for Clinical Affairs, University of Miami Miller School of Medicine
The Company plans to submit for journal publication in the future.
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: 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. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including the Company's ability to provide the FDA with the additional information it has requested, the results of the Company's pivotal study, 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 risk factors contained in the Company's Annual Report filed on Form 10-K and recently filed 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.