PROTECT I Data Support Abiomed's Impella 2.5

March 11, 2009—Abiomed, Inc. (Danvers, MA) announced that results from the company's trial evaluating the feasibility and effectiveness of the Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention (PCI) procedures have been published by Simon R. Dixon, MD, in the February 2009 issue of the Journal of the American College of Cardiology: Cardiovascular Interventions (2009;2:91-96). The PROTECT I (Prospective Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention) investigators concluded that the Impella 2.5 system is safe, easy to use, and provides excellent hemodynamic support during high-risk PCI.

According to the company, the PROTECT I trial enrolled 20 patients undergoing high-risk PCI at seven centers between July 2006 and April 2007. Eligible patients had left ventricular ejection fraction of less than 35% and were required to undergo PCI on either an unprotected left main coronary artery or the last patent coronary conduit. William W. O'Neill, MD, was the principal investigator for the study.

The Impella 2.5 received 510(k) clearance from the Food and Drug Administration in June 2008 for partial circulatory support for periods of up to 6 hours. The device is inserted percutaneously via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The Impella 2.5 is also CE mark approved. Abiomed stated that it is also conducting two US pivotal studies comparing the Impella 2.5 to the intra-aortic balloon pump (PROTECT II for high-risk percutaneous coronary intervention; and RECOVER II for acute myocardial infarction).