Pilot trial of Abiomed ’ s Impella as heart attack treatment meets endpoints, pivotal to follow

A pilot trial exploring the use of Abiomed‘s (NSDQ:ABMD) Impella heart pump as a treatment for reducing the severity of heart attacks has met its primary safety and feasibility endpoints, clearing the way for a pivotal trial, according to primary investigator Dr. Navin Kapur. Results from the pivotal, if successful, could “change the paradigm of heart attack management,” Kapur told MassDevice.com in an interview. Data from the pilot trial were announced today at the AHA Scientific Sessions 2018 in Chicago. “We’ve now demonstrated for the first time that [left ventricle] unloading, using the ImpellaCP device with a 30 minute delay before reperfusion is safe and feasible,” Kapur said, commenting on the pilot trial. “What we also learned was that among patients who have larger heart attacks, there was a significantly lower infarct size.” Even more importantly, the treatment could improve outcomes for heart failure patients. “If we can change infarct size by 5%, we think that this will reduce the global burden of heart failure due to heart attacks and will also improve not only short term mortality, but improve long term mortality for patients who are coming in with a heart attack. And that’s really the central goal of both the pilot and the pivotal trial,” Kapur said. For every 5% increase in heart damage after a heart attack, there’s a relative 20% increase in heart failure hospitalization at one year, and a 20% increa...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Abiomed Source Type: news