FDA approves clinical trial for Abiomed's minimally invasive ventricular assist device

By Lisa Kerner

Erie, Pa., May 25 - The Food and Drug Administration approved Abiomed, Inc.'s pilot clinical trial for the Impella 2.5 minimally invasive ventricular assist device (VAD), conditional upon the company's submission of additional data within the next 45 days.

Impella's indication for use is as support during high-risk angioplasty for up to five days as a left ventricular assist device, according to a company news release.

Abiomed said it plans to conduct the pilot investigation with no more than 20 patients at seven hospitals.

"We are very excited to receive this approval to begin the trial for our breakthrough Impella 2.5 product," chief executive officer Michael R. Minogue said in the release.

"We believe Impella will change the standard of care in the cath lab."

Located in Danvers, Mass., Abiomed develops medical products to assist or replace the pumping function of the failing heart.

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