Highlights the device role in left ventricular support for high-risk PCI procedures
Abiomed has presented the results from the Europella registry, evaluating the safety and feasibility of Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention (PCI) procedures. The results have been published in the December 15 issue of the Journal of the American College of Cardiology (JACC).
The company said that 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.
The company claims that the outcomes of the device include 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.
Jose Henriques of Academic Medical Center at University of Amsterdam, said: “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. These results indicate Impella’s ability to maintain hemodynamic support by safely unloading the left ventricle and decreasing oxygen demand in high-risk PCI patients.”
Michael Minogue, chairman, president and chief executive officer of Abiomed, said: “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.”