Abiomed presents PROTECT II study data in percutaneous coronary intervention at SCAI 2011

Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced results from further 90 day clinical and economic analyses, based on data from the PROTECT II study. The analyses showed a significant reduction of 29% in the Major Adverse Cardiac and Cerebrovascular Event (MACCE) rate for the Impella® arm at 90 days. Additionally, the Impella patient population had overall average hospital charge savings of $19,000 (all patients) to $22,000 (survivors only) without device costs included. With the device costs included, hospital charges with Impella ranged from being equivalent to $3,000 less than the intra-aortic balloon pump (IABP).

The analyses were presented by William O'Neill, M.D., executive dean for clinical affairs at the University of Miami Miller School of Medicine and principal investigator of the PROTECT II study, at the Society for Cardiovascular Angiography Interventions (SCAI) 2011 Scientific Sessions in Baltimore. The PROTECT II study was a prospective, multicenter, randomized trial, designed to measure a composite of major adverse events at 30 days, with 90-day follow-up in high-risk percutaneous coronary intervention (PCI) patients requiring hemodynamic support, comparing the Impella 2.5 to the IABP.

Summary and Conclusion of PROTECT II (Per Protocol):

1. Positive overall outcomes for the Impella arm over the IABP arm in the entire study cohort at 90 days, resulting in a 21% reduction in major adverse events over the IABP
2. In the pre-specified high-risk PCI without atherectomy subgroup (88% of study), Impella provided a significant benefit over the IABP at 30 days
3. There was a significant 29% reduction of the MACCE rate at 90-day follow-up per protocol in the Impella arm compared to the IABP arm

"The PROTECT II data continues to be clinically relevant, particularly at the 90-day mark," said Dr. O'Neill. "Our most recent analysis, presented today at SCAI, shows a significant reduction in MACCE in favor of Impella. This important finding provides new guidance for interventional cardiologists in selecting the appropriate type of support and its impact on patient care in high-risk PCI."

Economic Study Analysis:

In PROTECT II, Impella significantly reduced out-of-hospital major adverse events by 56%s latest release, the economic study includes additional patients and readmission data.

Hospital charges for all PROTECT II patients at 90 days averaged approximately $165,000 per patient for the IABP and approximately $146,000 for Impella, resulting in $19,000 lower charges with Impella support. Hospital charges for survivors only averaged approximately $156,000 per patient for IABP and approximately $134,000 for Impella, resulting in $22,000 lower charges with Impella support, excluding device costs.

Impella's reduction of overall hospital charges were driven by the following:

• 47% reduction in repeat revascularization for Impella patients at 90 days;
• 67% lower charges per readmission for Impella patients at 90 days.

The device costs were subtracted out of the economic study data and added back in at hospital cost assumptions. With device costs included ($20,000 for Impella, $800 for IABP), the hospital charges become equivalent at 90 days. Additional economic study information will be presented at a later date. This economic study was conducted by Presscott Associates, Ltd., an independent health economics organization. Analysis included third-party collection and analysis of medical billing data from actual claims submitted to payers.

"Reducing relevant clinical adverse events and lowering repeat revascularization rates unquestionably impacts readmissions at 90 days. These data represent a mutually beneficial scenario for the patients and payers, during a time when hospitals are continually scrutinized under new health reform payment models," said Michael R. Minogue, Chairman, President, and Chief Executive Officer, Abiomed.

"National delivery and payment reforms will accelerate the need for healthcare providers to show that clinical therapies improve quality and the use of healthcare resources," said David A. Gregory, MPA, FACHE, Executive Vice President, Presscott Associates, Ltd. "These economic findings demonstrate that the Impella therapy as compared to the IABP are powerful, in that they show Impella reduced the need for the patient to repeat the PCI procedure, which is a benefit to hospitals, payers, and certainly to the patient from a quality of life perspective."