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News Release - September 19, 2011
Abiomed Announces First Patient Enrolled In MINI-AMI StudyCRISP-AMI Trial Demonstrates Large Infarcts in Stable STEMI Patient Population
DANVERS, Mass.--(Healthcare Sales & Marketing Network)-- Abiomed, Inc. (NASDAQ:ABMD ), a leading provider of breakthrough heart support technologies, today announced the first patient enrolled in MINI-AMI, an FDA prospective, randomized, controlled multi-center study to assess the role of 24-hours of direct unloading of the left ventricle with Impella® 2.5 support to reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) without cardiogenic shock. The patient was enrolled at the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston and implanted by Guilherme Silva, M.D.
MINI-AMI is a feasibility study designed with the exploratory intent to determine whether direct unloading of the left ventricle can be effective in treating this stable STEMI patient population, which represents 330,000 patients a year, according to the American College of Cardiology (ACC) and American Heart Association (AHA) 2009 Guidelines for STEMI and percutaneous coronary intervention (PCI). Although this study is not powered to show a statistical difference in the primary endpoint, the results will provide guidance towards future larger investigations. The study will enroll a total of 60 acute myocardial infarction (AMI) patients requiring primary PCI, including 10 roll-in patients at a maximum of five institutions. Patients will be randomized to PCI+Impella vs. PCI-only arms. The study will assess the infarct size using a magnetic resonance imaging (MRI) technique.
“We are very excited to be the first to enroll in the exploration of infarct size reduction,” said Andrew Civitello, M.D, principal investigator at Texas Heart Institute at St. Luke’s Episcopal Hospital. “The MINI-AMI study will give us a first look at the potential benefit of Impella in this large patient population, which is currently untreated by any type of direct ventricular support.”
Relative to this stable STEMI patient population, results were recently released from the Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction (CRISP AMI) trialą. The CRISP AMI trial determined that routine intra-aortic balloon pump (IABP) placement prior to reperfusion in patients with STEMI without cardiogenic shock, did not reduce myocardial infarct size. A total of 337 patients were randomized at 30 sites, with one group receiving IABP+PCI and the other group receiving PCI treatment alone. The median infarct size was 37.5% in patients treated with PCI-only and trended larger in the IABP+PCI arm with 42.1% infarct size (P=0.06).
Although the recently published CRISP AMI results did not show an infarct size reduction or clinical benefit of IABP and further discourages its routine use in this category of patients, the study itself has provided insight on the extent of the infarct size in stable STEMI patients and measuring outcomes of AMI beyond the survival benefit.
“The large infarcts observed in the CRISP AMI trial overall emphasize a significant clinical need for patients who are treated within recommended door-to-balloon times and still sustain significant myocardial damage. It is a great example of the need for an effective myocardial salvage strategy which can be provided through direct ventricular unloading by a device such as Impella,” said Jeff Moses, M.D., Columbia University Medical Center/New York-Presbyterian Hospital and co-principal investigator of the MINI-AMI study.
The CRISP-AMI trial results were published online by the Journal of the American Medical Association and were recently discussed in a TCTMD webcast on September 13, which is available at:http://www.tctmd.com/ESCWebcast/
1. Patel, MR, Smalling RW, Thiele H, et al. Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: The CRISP AMI randomized trial. JAMA 2011; DOI:10.1001/jama.2011.1280
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, the Company’s projected revenues, 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, 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. 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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