FDA Approves ABIOMED VAD Clinical Trial
ABIOMED Inc. is commencing its pilot clinical trial in the U.S. for the IMPELLA 2.5 minimally invasive ventricular assist device (VAD) after recent FDA approval. The approval is conditioned upon the company’s submission of additional information to the FDA within a limited time frame.
The Impella Recover 2.5, an investigational device, allows the heart to rest and recover by actively unloading the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output, coronary and end-organ perfusion.
The indication for use is support during high-risk angioplasty for up to five days as a left VAD. High-risk angioplasty is defined as angioplasty on an unprotected left main coronary artery lesion, or the last patent coronary conduit, and poor cardiac function. The company intends to conduct the pilot investigation on the IMPELLA 2.5 with no more than seven hospitals and 20 patients.