The FDA has expanded its premarket approval for Impella heart pumps to include treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, device manufacturer Abiomed announced Feb. 13.
The Impella pumps, which provide circulatory support, were previously approved in April 2016 to treat patients in acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock.
"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, Hackensack University Medical Center’s chief of cardiac surgery and surgical director of mechanical circulatory support, said in a press 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."
The FDA’s approval covers the Impella 2.5, Impella CP, Impella 5.0 and Impella LD pumps, including for indications of cardiogenic shock associated with peripartum and postpartum cardiomyopathy (PPCM).
Related to these issues, Abiomed also announced its Women's Initiative for Heart Recovery. PPCM is a leading cause of pregnancy related death in the U.S., with a mortality rate of 10 percent, according to the company. Cardiogenic shock is common in these fatal cases.
Spontaneous coronary artery dissection (SCAD) is another condition affecting younger women (average age of 42) and can lead to heart attack and cardiogenic shock. The Impella heart pumps are now FDA-approved to treat both PPCM and SCAD in these instances.
"The Impella platform provides a new treatment option for women suffering from cardiogenic shock caused by cardiomyopathy," said Cindy Grines, MD, chair of the Zucker School of Medicine at Hofstra/Northwell Health. "Additionally, unloading the heart so it can rest has the potential to improve outcomes specifically around heart recovery for this young postpartum population. Education and patient awareness are also critical to properly diagnose and treat these patients."
Said Michael R. Minogue, president, chairman and CEO of Abiomed: "With our expanded indication, we can invest in education and awareness as we launch our Women's Initiative for Heart Recovery. Abiomed will establish a new physician and patient advisory board to make heart recovery the standard of care for women suffering from cardiogenic shock."