Study results of Impella 2.5 circulatory assist device in high-risk PCI procedures published

Dec 18 2009

Results from the Europella registry, evaluating the safety and feasibility of the Abiomed, Inc. (NASDAQ: ABMD) Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention (PCI) procedures have been published in the December 15 issue of the Journal of the American College of Cardiology (JACC). The paper, “Supported High-Risk Percutaneous Coronary Intervention Using the Impella 2.5 device: The Europella Registry” concludes, “this large multicenter registry supports the safety, feasibility and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.”

“As high-risk PCI increasingly becomes the alternative for patients turned down for surgery, the Europella registry demonstrates that Impella 2.5 proves a safe and effective method of support for these high-risk procedures,” said Jose PS Henriques, M.D., Ph.D., Academic Medical Center, University of Amsterdam. “These results are very encouraging in indicating Impella’s ability to maintain hemodynamic support by safely unloading the left ventricle and decreasing oxygen demand in high-risk PCI patients.”

The Europella registry is the largest multicenter study ever reported for high risk PCI conducted with Impella, including 144 consecutive high-risk PCI patients with complex or high risk coronary lesions, such as last remaining vessel or left main lesions, from ten European centers, and reported the following:

Patient Population

• Patients were older, 62% older (Mean age, 71.8 years)
• 54% had an LV ejection fraction of 30% or less
• The prevalence of comorbidities was high and the Mean European System for Cardiac Operative Risk Evaluation score was 8.2± 3.4
• 43% of the patients were refused for CABG
• Left main coronary artery (LMCA) PCI, last patent vessel PCI, and complex multivessel disease (MVD) comprised 52%, 17%, and 82% of the cases, respectively

Device Outcomes

• Successful passage through the femoral artery and implantation of the Impella 2.5 into the left ventricle was achieved in all 144 patients
• The study showed a low rate of major adverse cardiac and cerebrovascular, 0% device malfunction and low rate of complications confirming the safety, ease of use and potential effectiveness of the technology for high risk PCI. The primary feasibility endpoint included successful deployment, operation and explantation of the Impella 2.5.

“We are pleased with the positive results from the Europella registry. These data reinforce the Impella 2.5 clinical papers that are continuing to be released, such as USpella, which was announced at TCT 2009,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed.