The FDA expanded the approval of Abiomed’s premarket approval for the company’s Impella CP heart pump for use in high risk PCIs.
In April, the FDA approved the Impella CP, Impella 2.5, Impella 6.0 and Impella LC for short-term use in patients suffering from cardiogenic shock that occurs within 48 hours of an acute MI or open heart surgery. The approval is intended for patients who did not respond to optimal medical management and conventional treatment.
The expanded approval, which was announced Dec. 7, pertains to use of the Impella CP during high risk PCIs. It is intended for elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.
The approval was based on registry data and results of a few studies. One randomized trial found that patients who received Impella heart pumps had a 29 percent reduction in major adverse events, a 58 percent increase in quality of life and superior hemodynamics and improved cardiac power compared with patients who received an intra-aortic balloon pump.
Abiomed said in a news release that it would conduct post-market surveillance of the Impella heart pumps through its cVAD registry. The company added that approximately 121,000 high-risk patients in the U.S. have chronic, advanced, inoperable heart disease.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.