Abiomed seeks expanded PMAs for Impella heart pump line

Abiomed (NSDQ:ABMD) said today it submitted PMA applications to expand indications for its Impella line of percutaneous micro heart pumps to patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.

In addition to the new indication, the Danvers, Mass.-based company also submitted an application for longer duration use, Abiomed said.

The submissions include a 415-patient analysis of the FDA’s Recover 1 study, a 692-patient literature review and a safety analysis of over 24,000 impella patient in the FDA/Medical Device Reporting database, according to the company.

The applications would extend clearances Abiomed won in March for the Impella 2.5 to the entire Impella line, including the CP and 5.0 models of the device, Abiomed said.

Last week, Abiomed released information about a slew of new pipeline products.

Pipeline products included an expanded cardiac power pump labeled the ECP, a next-gen Impella CP and 5.0, as well as a bridge-to-recovery system that would have a permanent time frame on implant of months to years.

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