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Heart pumps approved to treat ongoing cardiogenic shock

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Abiomed announced it has received FDA premarket approval for its heart pumps for treatment of ongoing cardiogenic shock occurring within 48 hours of acute MI or after open-heart surgery.

The heart pumps (Impella 2.5, Impella CP, Impella 5.0 and Impella LD, Abiomed) provide hemodynamic support, reduce volume in the left ventricle, and provide end-organ perfusion to allow the heart to recover, according to a press release.

These are the first percutaneous temporary ventricular support devices to receive FDA approval for a cardiogenic shock indication, according to the release.

“I am hoping that this will be a wake-up call for the broader cardiology community to try to get more patients treated and to treat patients earlier,” William W. O’Neill, MD, FACC, FSCAI, medical director of the Center for Structural Heart Disease at Henry Ford Hospital, told Cardiology Today’s Intervention in an interview.

William W. O’Neill

The Impella 2.5, Impella CP, Impella 5.0 and Impella LD catheters, which work in conjunction with an automated controller console, are only indicated for patients who are not responsive to optimal medical management and standard care procedures with or without an intra-aortic balloon pump, according to the release. They are meant for temporary usage: less than 4 days for the Impella 2.5 and Impella CP, and less than 6 days for the Impella 5.0 and Impella LD. However, product labeling indicates that the pumps can be left in longer if deemed medically necessary, according to the release.

Data from 415 patients from the RECOVER 1 study and the U.S. Impella registry, as well as 692 patients from a literature review of 17 clinical studies and more than 24,000 patients from a real-world safety analysis were used in the approval process.

The Impella 2.5 is already FDA-approved for high risk PCI or protected PCI.

“Based on my own personal experience, I think it is a lifesaving device that is really very potent in preventing shock and in supporting patients when they develop shock to help them recover,” O’Neill, a Cardiology Today’s Intervention Editorial Board member. said in an interview. “So I think it is a wonderful tool that has been around awhile, but now we have clear evidence that it is safe and effective in shock patients.” – by Tracey Romero

Disclosure: O’Neill reports no relevant financial disclosures.