Data Shows EF Improves with Abiomed’s Impella 2.5
March 29, 2007 —Data on Abiomed Inc.’s Impella 2.5 were presented at the American College of Cardiology's (ACC) 56th Annual Scientific Sessions by Drs. Krischan D. Sjauw, Maurice Remmelink, Jan Baan, Jr., Rene J. van der Schaaf, Marije M. Vis, Karel T. Koch, Jan G. Tijssen, Jan J. Piek, Robbert J. de Winter, and Jose P. Henriques.
The study — titled "Preliminary Experience of the MACH 2 Trial: Safety and Feasibility of Left Ventricular Support With the Impella Recover LP 2.5 Device in Patients With Acute ST-Segment Elevation Myocardial Infarction" — found that the Impella 2.5 improved cardiac function for pre-shock acute myocardial infarction (AMI or heart attack) as compared to conventional routine care including intra-aortic balloon pump (IABP) therapy.
"We have already published on the safety of the Impella 2.5 technology,” said Dr. J.P.S. Henriques, cardiologist at the Academic Medical Center in Amsterdam. “Today we provide the first human study that documents the benefit of the Impella 2.5 to improve the left ventricular function post acute myocardial infarction as evidenced by the left ventricular ejection fraction.”
The 20 patient study looked at patients who were admitted for an AMI with hemodynamic instability, had the necessary procedure to re-open the blocked artery, and then received the Impella 2.5 or standard routine care including intra-aortic balloon-pump for a few days. The preliminary results showed that patients supported by the Impella 2.5 technology had significantly improved cardiac function at three days and four months after the heart attack as compared to the control group. The preliminary results showed an increase in ejection fraction of 9 percent and 13 percent at three days and four months, respectively in the Impella 2.5 group as compared to 2 percent and 5 percent in the control group.
The Impella 2.5 is a ventricular assist catheter that is inserted percutaneously in the catheterization laboratory 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 can be inserted quickly and provides cardiovascular support for up to five days. The device is currently available in Europe under CE Mark approval and is currently in pilot studies in the U.S. under an Investigational Device Exemption.