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Percutaneous heart pumps gain new indications
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Abiomed announced the FDA approved its percutaneous heart pumps for treatment of HF associated with cardiomyopathy leading to cardiogenic shock.
The pumps (Impella 2.5, Impella CP, Impella 5.0 and Impella LD) were previously approved to treat acute MI with cardiogenic shock and post-cardiotomy cardiogenic shock.
The company also announced the launch of a new Women’s Initiative focusing on heart recovery education and awareness in conjunction with the new indication.
In conjunction with a controller, the pumps are intended to provide temporary short-term ventricular support (4 days or less for the Impella 2.5 and CP devices; 6 days or less for the Impella 5.0 and LD devices), according to the release.
The new indication now allows the pumps to be used in patients with cardiomyopathy, including peripartum and postpartum cardiomyopathy and myocarditis resulting from isolated left ventricular failure that does not respond to other treatments, according to the release.
“With this approval, physicians now have a new FDA-approved treatment option for patients in cardiogenic shock caused by cardiomyopathy,” Cindy L. Grines, MD, FSCAI, chair of the Zucker School of Medicine at Hofstra and Northwell Health, told Cardiology Today. “Impella devices offer the entire heart team, consisting of interventional cardiologists, HF specialists and heart surgeons, a minimally invasive treatment option that can be implanted through the femoral artery or via the subclavian artery in a short time frame, which avoids the need for a sternotomy.”
Cardiomyopathy is responsible for 1.8 million hospitalizations per year in the United States and is associated with a 30% mortality rate at 1 year after admission, according to the release.
“In the setting of cardiomyopathy with cardiogenic shock, the Impella heart pump platform stabilizes the patient’s hemodynamics and directly unloads the heart providing blood flow to the body’s organs,” George Batsides, MD, FACC, chief of cardiac surgery and surgical director of mechanical circulatory support at Hackensack Medical Center, said in the release. “The goal of this therapy is to rest the heart muscle allowing recovery to the patient’s baseline function. This treatment is the ideal solution to restore a patient’s quality of life especially for patients older than 65 and not eligible for heart transplant.”
Disclosure: Grines reports she has served on an advisory board for Abbott Vascular and receives speaking honoraria from Abiomed. Batsides reports no relevant financial disclosures.