Health & Fitness
Health and Fitness
Health and Fitness
Fri, September 24, 2010
Thu, September 23, 2010
DANVERS, Mass.--([ BUSINESS WIRE ])--[ Abiomed, Inc ]. (NASDAQ: ABMD), a leading provider of [ breakthrough heart support technologies ], today announced updated clinical data from USpella, a U.S. multicenter, observational registry of [ Impella 2.5 ]® patients.
The new updates, presented today at TCT 2010 reported that 24 U.S. and Canadian centers have contributed data for a total of 352 patients. The USpella registry results were last announced on May 15, 2010 at EuroPCR 2010.
The updated USpella results were presented today at TCT 2010 during an Abiomed TCT breakfast session by William Oa™Neill, M.D., University of Miami Miller School of Medicine. The results were also presented by Brijeshwar Maini, M.D., Pinnacle Health and Vascular Institute, during TCT Session III: Optimizing Primary PCI for STEMI in the Cath Lab.
The updated USpella registry* reported the following:
After Prophylactic Impella Supported Revascularization:
- Significant (17%) improvement of LVEF
- Significant improvement (49% of patients) in New York Heart Association (NYHA) class with 61% reduction in NYHA class four
- Significant (25%) reduction in ICD target population, leading to potential cost savings
- More than half of the patients (54%) were turned down for CABG, 59% of the patients had experienced a prior myocardial infarction (MI)
- Low mortality (3.9%) and MACE event rate (8.2%) in patients, compared to high risk PCI literature**
After Emergent Impella Support:
- Hemodynamic support with the Impella 2.5 (Cardiac Index, Cardiac Power Output, Wedge Pressure, Mean Arterial Pressure) significantly increased over the IAB in this study
- Impella improves Cardiac Power Output (CPO), the strongest correlate of in-hospital mortality (CPO increased from 0.5 0.2 before Impella support to 1.0 + 0.2 after Impella support)
- Significant (19%) improvement of LVEF at discharge
- Significant reduction (59%) in mortality in the group that received Impella before PCI
- Ninety percent of the survivors recovered native cardiac function and were discharged with their own hearts
*Significant = statistically significant with p <0.05
**Syed Al, et al. Cardiovasc Revasc Med 2010, 1191-7
Acronym definitions: LVEF = left ventricular ejection fraction, CABG= coronary artery bypass graph or heart surgery, IAB = intra-aortic balloon, MACE = major adverse cardiac events, ICD = implantable cardiac defibrillator
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 The results to date of the USpella registry. The actual results of the USpella registry may differ materially in the future and 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.
Impella is a registered trademark of Abiomed Europe GmbH, a subsidiary of Abiomed, Inc.
