The FDA approved the Impella heart pumps on April 7 to treat patients with ongoing cardiogenic shock following acute MI or open heart surgery as a result of isolated left ventricular failure.
The pre-market approval is for the Impella 2.5, Impella CP, Impella 5.0 and Impella LD catheters in conjunction with the automated Impella controller console. The devices are now approved for short-term use (four days or fewer for the Impella 2.5 and CP and six days or fewer for the Impella 5.0 and LD) in patients who do not respond to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump.
Abiomed, the Impella’s manufacturer, said in a news release that physicians are allowed to keep the device in place beyond the four- to six-day period due to unforeseen circumstances.
The approval was based on results of an analysis of 415 patients from a clinical trial and Impella registry as well as a literature review of 692 patients who were treated with Impella in 17 studies. For a safety analysis, Abiomed also provided data on more than 24,000 patients who received the Impella over a seven-year period.
“This approval sets a new standard for the entire cardiovascular community as clinicians continue to seek education and new approaches to effectively treat severely ill cardiac patients with limited options and high mortality risk,” William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital, said in a news release. “The Impella heart pumps offer the ability to provide percutaneous hemodynamic stability to high-risk patients in need of rapid and effective treatment by unloading the heart, perfusing the end organs and ultimately, allowing for the opportunity to recover native heart function.”
The FDA granted the Impella 2.5 pre-market approval for high-risk PCI in March 2015 and granted the Impella RP device a Humanitarian Device Exemption approval in January 2015.