FDA News

FDA approves expanded labeling for two heart pumps for cardiogenic shock

Abiomed announced that two of its heart pumps have received approval from the FDA for expanded premarket labeling to support patients with cardiogenic shock for 14 days.

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Abiomed announced that two of its heart pumps have received approval from the FDA for expanded premarket labeling to support patients with cardiogenic shock for 14 days.
Adobe Stock

The duration of support from the two heart pumps (Impella 5.0, Impella LD) was previously 6 days before the updated indication, according to a press release from the company. The return to baseline heart function or the potential of native heart recovery may be achieved with both heart pumps by unloading the left ventricle, stabilizing hemodynamics and perfusing end organs. The Impella LD heart pump is implanted into the aortic, whereas the Impella 5.0 heart pump is implanted through the axillary or femoral artery, according to the release.

“Early recognition, escalation and a heart team approach are crucial for patients in cardiogenic shock,” Jacob Abraham, MD, HF cardiologist and medical director of the Center for Advanced Heart Disease at Providence St. Vincent Medical Center in West Haven-Sylvan, Oregon, said in the release. “The Impella 5.0 and Impella LD’s ability to provide greater hemodynamic support and unload the left ventricle make them ideal tools for patients ... who need longer duration support and will benefit from ambulation.”

Both pumps have received premarket approval from the FDA in 2016 for the treatment of cardiogenic shock in patients with MI, in addition to patients with shock linked to myocarditis or peripartum cardiomyopathy, according to the release.

Disclosure: Abraham reported he was a consultant for Abbott and Abiomed and a site investigator for trials sponsored by Abbott, and has received speaker honoraria from Abbott and Abiomed.

Abiomed announced that two of its heart pumps have received approval from the FDA for expanded premarket labeling to support patients with cardiogenic shock for 14 days.

#
Abiomed announced that two of its heart pumps have received approval from the FDA for expanded premarket labeling to support patients with cardiogenic shock for 14 days.
Adobe Stock

The duration of support from the two heart pumps (Impella 5.0, Impella LD) was previously 6 days before the updated indication, according to a press release from the company. The return to baseline heart function or the potential of native heart recovery may be achieved with both heart pumps by unloading the left ventricle, stabilizing hemodynamics and perfusing end organs. The Impella LD heart pump is implanted into the aortic, whereas the Impella 5.0 heart pump is implanted through the axillary or femoral artery, according to the release.

“Early recognition, escalation and a heart team approach are crucial for patients in cardiogenic shock,” Jacob Abraham, MD, HF cardiologist and medical director of the Center for Advanced Heart Disease at Providence St. Vincent Medical Center in West Haven-Sylvan, Oregon, said in the release. “The Impella 5.0 and Impella LD’s ability to provide greater hemodynamic support and unload the left ventricle make them ideal tools for patients ... who need longer duration support and will benefit from ambulation.”

Both pumps have received premarket approval from the FDA in 2016 for the treatment of cardiogenic shock in patients with MI, in addition to patients with shock linked to myocarditis or peripartum cardiomyopathy, according to the release.

Disclosure: Abraham reported he was a consultant for Abbott and Abiomed and a site investigator for trials sponsored by Abbott, and has received speaker honoraria from Abbott and Abiomed.