FDA approves emergency use of Abiomed’s Impella RP heart pump for certain COVID-19 patients
The FDA has issued an emergency use authorization (EUA) for Abiomed’s Impella RP heart pump as a treatment option for COVID-19 patients with right-sided heart failure.
The EUA covers patients who experience right-sided heart failure following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery.
“We appreciate the work of physicians and healthcare providers to treat these difficult patients and thank the FDA for its emergency use authorization for Impella RP,” Michael R. Minogue, Abiomed chairman, president CEO, said in a statement. “We are committed to helping our customers improve the outcomes of their patients with our percutaneous heart pumps during these COVID-19 times.”
“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19,” Amir Kaki, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, said in the same statement. “Impella RP is an important tool to help cardiologists save lives during this pandemic. As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be life-saving.”
The FDA explored data from numerous studies before issuing the EUA, including three that were specifically focused on the heart pump’s ability to improve right ventricular function in patients with pulmonary embolism.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.