DANVERS, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced results of an economic study at the annual 2011 Transcatheter Cardiovascular Therapeutics (TCT) conference. The economic study demonstrated that Impella significantly reduced major adverse events at an incremental cost per quality-adjusted life year considered to be cost-effective for advanced cardiovascular technologies. Quality of life benefits included an increase in ejection fraction of over 20% and an improvement in New York Heart Association (NYHA) Class III and Class IV heart failure of over 50%.
This study was performed by Prescott Associates and the Harvard Clinical Research Institute (HCRI), utilizing data on patients enrolled in the PROTECT II trial, which is the first randomized trial comparing prophylactic use of hemodynamic support in patients with depressed left ventricular function and complex anatomy. The study demonstrated a gain in quality of life for Impella patients over the current standard of care, the intra-aortic balloon pump (IABP), at an incremental cost-effectiveness ratio (ICER) of $39,400, below the $100,000 threshold commonly used in the United States.
The economic study results were consistent with overall PROTECT II 90 day clinical outcomes previously released. In the 90 days following initial hospitalization, Impella patients experienced:
- 50% lower re-hospitalization costs compared to the IABP (p=0.023);
- 58% reduction in hospitalizations due to repeat revascularization (p=0.024);
- Two fewer days in the hospital (p=0.001)
“National delivery and payment reforms will accelerate the need for healthcare providers to show that clinical therapies improve quality of life and justify the use of healthcare resources,” said David A. Gregory, MPA, FACHE, Executive Vice President, Presscott Associates, Ltd., a leading health economics firm. “These economic findings on the Impella therapy as compared to the IABP are meaningful, demonstrating that Impella reduces adverse events including the need for multiple procedures over time, which is a benefit to hospitals, payers, and certainly to the patient from a quality perspective.”
“We are excited to see the clinical benefits of Impella translating into economic value for payers and providers, particularly in this era of accountable care,” said Michael R. Minogue, Chairman, President, and Chief Executive Officer, Abiomed. “These data demonstrate that PCI is valuable and identifies a new, cost-effective, minimally invasive alternative for many of these high risk chronic heart failure patients. We believe that hemodynamic support with Impella represents a new paradigm of cost-effective treatment that directly correlates with the patient’s quality of life.”
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.
ABOUT PROTECT II
The PROTECT II study is the first randomized, multicenter trial, designed to measure a composite of major adverse events at 30 days, with 90 day follow-up in high risk PCI patients randomized to receive hemodynamic support, comparing the Impella 2.5 versus the IABP.
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 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 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 the 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.
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