Abiomed, FDA Reach Agreement on Impella Indications

Abiomed has come to an agreement with the FDA on indications for the company’s Impella CP, 2.5, 5.0 and LD devices and doesn’t expect a need for review from an FDA advisory panel, the company said.

According to a Securities and Exchange Commission filing, based on discussion between Abiomed and the agency and available information, the company believes a panel review prior to PMA approval is no longer necessary.

The devices are indicated for use in patients suffering from cardiogenic shock following acute myocardial infarction or cardiac surgery. — Anisa Jibrell