Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock

Medical Device Investing

Abiomed (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has received an expanded U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5®, Impella CP®, Impella 5.0® and Impella LD® heart pumps to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock. …

As quoted in the press release:

The data submitted to the FDA in support of this expanded PMA indication included an analysis of 93 patients from Abiomed’s FDA reviewed cVAD Registry study, as well as a comprehensive literature review including 109 patients treated with Impella from 32 clinical publications. This clinical data is reinforced by prior FDA studies demonstrating the safety and effectiveness of Impella support in both elective and emergent patient populations.

Click here to read the full press release.

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