Abiomed to Present Impella(R) 2.5 Clinical Data at TCT 2007 and Showcase Cath Lab & Surgery Suite Heart Recovery Technologies.* Live Broadcasts of Impella Procedures and Leading Clinician Presentations on Recovery * Satellite Symposium: Dr. William O'Neill, Principal Investigator, Impella 2.5 Clinical Trial WASHINGTON -- Abiomed Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ABMD ABMD areal bone mineral density ABMD AEGIS Ballistic Missile Defense (US Navy) ABMD Advanced Ballistic Missile Defense ), today announced its schedule of events at the Cardiovascular Research Foundation's (CRF CRF abbr. chronic renal failure CRF Chronic renal failure ) annual Transcatheter Cardiovascular Therapeutics (TCT TCT The Capital Times (Madison, WI newspaper) TCT Transcatheter Cardiovascular Therapeutics TCT The Coroner's Toolkit TCT Trans Canada Trail TCT Tcl Core Team TCT Tsukuba College of Technology (Japan) ) 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 ventricular assist device: see under heart, artificial. (VAD (Value Added Dealer) Same as VAR. ), including results from a multi-center feasibility study of adult patients that had high-risk Percutaneous Coronary Interventions (PCI (1) (Payment Card Industry) See PCI DSS. (2) (Peripheral Component Interconnect) The most widely used I/O bus (peripheral bus). ). 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 acute myocardial infarction ( n. Shock resulting from a decline in cardiac output that occurs as a result of serious heart disease, especially myocardial infarction. , 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 intra-aortic balloon pump n. A pump connected to a balloon device that is inserted into the descending aorta to provide temporary assistance to the heart in the management of left ventricular failure. (IABP IABP intra-aortic balloon pump. ) during "high-risk" PCI procedures. The study inclusion criteria have been extended to include patients with triple vessel disease with low ejection fraction ejection fraction n. The blood present in the ventricle at the end of diastole and expelled during the contraction of the heart. 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 (1) See Internet Architecture Board. (2) (Interactive Advertising Bureau, New York, www.iab.net) An industry association founded in 1996 to set standards and guidelines for interactive advertising and marketing. ) and iPulse(TM) Console Platform, the AB5000[TM] 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 This article is about the university in Coral Gables, Florida. For the university in Oxford, Ohio, see Miami University. The University of Miami (also known as Miami of Florida,[2] UM,[3] or just The U 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 angiology /an·gi·ol·o·gy/ (an?je-ol´ah-je) the study of the vessels of the body; also, the sum of knowledge relating to the blood and lymph vessels. an·gi·ol·o·gy n. , 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 Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare. * "Recovering the Dysfunctional Heart: Is it Time for a Paradigm Shift in Management of ACS (Asynchronous Communications Server) See network access server. ?," 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 One of the nation’s leading academic medical centers, Robert Wood Johnson University Hospital provides state-of-the-art care across the full range of health care services. * "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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