Abiomed presents Impella PROTECT II study final results in PCI at ACC and i2 Summit

Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced the final results from the PROTECT II study, presented by William O'Neill, M.D., Dean of University of Miami and Principal Investigator of PROTECT II, at the American College of Cardiology's (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans. The results included data from the entire study population and demonstrated a significant positive overall outcome for per-protocol patients treated with Impella® 2.5 at 90 days.

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 intra-aortic balloon pump (IABP).

Summary and Conclusion of PROTECT II (Per-Protocol):

1. Positive overall outcome 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. In the pre-specified atherectomy group (12% of study), there was no overall statistical difference
4. Impella significantly reduced out-of-hospital major adverse events overall by 56%
5. The PROTECT II study was prematurely halted in December 2010 per the recommendation of the Data Safety Monitoring Board based on the 50% interim enrollment data with the assumption that it would not meet its primary endpoint at 30 days. The treatment effect of Impella over IABP improved during the course of the trial, suggesting a learning curve. The superior hemodynamic support of Impella appears to have led to significant procedural differences between the two arms. The original study was powered at 80% with the intended final population of 654 patients. The interim report included the 50% mark and final analysis included an additional 19% of patients. The pre-specified "roll-in subject" analysis demonstrated that, without the first patient in both arms, Impella was significantly better at 90 days