October 16, 2007 - Abiomed Inc. will be presenting clinical data on Impella 2.5 percutaneous Ventricular Assist Device (VAD), including results from a multi-center feasibility study of adult patients that had high-risk Percutaneous Coronary Interventions (PCI), at the Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting, scheduled from Saturday, October 20, to Thursday, October 25, in Washington, D.C.
The Impella 2.5 is reportedly the world’s smallest VAD, which provides patients with up to 2.5 liters of blood flow per minute and has been used under CE Mark approval in Europe to treat conditions such as acute myocardial infarction (heart attack), cardiogenic shock and low output syndrome.
Due to a rise in conditions such as triple vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three vessels of the heart, the Impella 2.5 provides a new treatment option that aims to improve patient outcomes.
The Impella 2.5 was approved in August 2007 by the FDA for a pivotal study that will determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP) during high-risk PCI procedures.
The study inclusion criteria have been extended to include patients with triple vessel disease with low ejection fraction. The clinical experience to date with Abiomed’s Impella 2.5 has been favorable, including its recently completed U.S. safety pilot clinical trial.
For more information: www.abiomed.com