Abiomed Inc. (NASDAQ: ABMD), today announced its schedule of events at the Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting, scheduled from Saturday, October 20, to Thursday, October 25, in Washington, D.C.
Abiomed will be announcing clinical data on its breakthrough Impella 2.5 percutaneous Ventricular Assist Device (VAD), including results from a multi-center feasibility study of adult patients that had high-risk Percutaneous Coronary Interventions (PCI). The Impella 2.5 is the world's smallest VAD which provides patients with up to 2.5 liters of blood flow per minute and has been used under CE Mark approval in Europe to treat conditions such as acute myocardial infarction (heart attack), cardiogenic shock, and low output syndrome. Due to a rise in conditions such as triple vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three vessels of the heart, the Impella 2.5 provides a new treatment option that aims to improve patient outcomes. Additionally, at Booth 6121, Abiomed will showcase its complete portfolio of heart recovery products across the continuum of patient care from the cath lab, to the intensive care unit, to the surgery suite.
“We are excited to unveil new data for our breakthrough Impella technology, and present live broadcasts of patient procedures at hospitals around the world,” said Michael R. Minogue, Chairman, President and CEO of Abiomed. “The combination of our Satellite Symposium, leading physician presentations, and our product demonstrations at TCT are all focused on establishing heart recovery as the goal for patients.”
The Impella 2.5 was approved in August 2007 by the FDA for a pivotal study that will determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP) during "high-risk" PCI procedures. The study inclusion criteria have been extended to include patients with triple vessel disease with low ejection fraction. The clinical experience to date with Abiomed’s Impella 2.5 has been favorable, including its recently completed U.S. safety pilot clinical trial. The technology is now approved in more than 40 countries, and is available in Europe under the CE Mark. Impella has been the subject of more than 20 peer-reviewed publications including the April 2006 American Journal of Cardiology (Volume 97, Issue 7) publication on high-risk angioplasty.
Included in the Abiomed TCT booth will be demonstrations of the company’s extensive heart recovery product suite including Impella, its intra-aortic balloon (IAB) and iPulseTM Console Platform, the AB5000™ Circulatory Support System, and the world’s only fully-implantable artificial heart, the AbioCor.
Abiomed Schedule of Events:
Sunday, October 21
Satellite Symposium. From 8:00 to 10:00 p.m. TCT symposium sponsored by Abiomed entitled, “Impella: Redefining the Standard of Circulatory Support for Acute Heart Failure,” chaired by Dr. William O'Neill, MD, Executive Dean for Clinical Affairs, University of Miami Miller School of Medicine, in the Renaissance Ballroom of the Renaissance Hotel. A reception will be held prior to the symposium at 7:30 p.m. To register, please access http://www.abiomed.com.
This symposium will serve as a forum for the first public announcement of the results of the PROTECT I trial.
Symposium topics and speakers will include:
- “Future Perspectives of Circulatory Support in Acute Heart Failure: Rationale for a Continuum of Care,” Eberhard Grube, MD, 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?,”Fred Resnic, MD, 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?,”J.P.S. Henriques, MD, Department of Cardiology, Academic Medical Centre, University of Amsterdam, Netherlands
- “Bridging the Gap Between Cardiology and Surgery: What Makes Sense for Our Patients?,”Magnus Ohman, MD, Director, Program for Advanced Coronary Disease Division of Cardiology, Duke University
- “Recovering the Failing Heart in Profound Shock Conditions: Surgical VAD Improves Outcomes," Mark B. Anderson, MD, 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?,”William O'Neill, MD, Executive Dean for Clinical Affairs, University of Miami Miller School of Medicine
Wednesday, October 24
8:00 a.m. Dr. Simon R. Dixon of William Beaumont Hospital, Royal Oak, Michigan will present "Impella: Safety and Clinical Utility of a Temporary Transaortic Forward Flow Hemodynamic Support Device" in room 151AB. 8:48 a.m. Room 151AB, Dr. Mark Anderson will present "Recovery of Left Ventricular Function in Cardiogenic Shock after Temporary LVAD Implantation: Experience with IMPELLA 5.0 and Implantable VADs". 11:14 a.m. Dr. Robert D. Dowling, Professor of Surgery at the University of Louisville School of Medicine and Jewish Hospital, will present on the "AbioCor Implantable Replacement Heart: Indications, Complications, and the Clinical Role," in room 151AB. 4:20 p.m. Room 151AB, Dr. Laura Mauri will present new data from the PROTECT I trial: "Feasibility Trial Investigating the Use of the IMPELLA(R) RECOVER(R) LP 2.5 System in Patients Undergoing High Risk PCI." Study results will examine the potential efficacy and the frequency of serious adverse events associated with use of the Impella Recover LP 2.5 System in adult patients who are considered high risk for PCI procedures.
- Live Broadcasts of Impella Cases transmitted from hospitals around the world.
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: 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. 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 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.
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