Abbott’s device had been cleared in 2013 for primary (or degenerative) mitral regurgitation. The expanded indication includes patients who have moderate-to-severe or severe mitral regurgitation because of diminished left heart function despite being treated with optimal medical therapy.
“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option,” said Bram Zuckerman, MD, director of the FDA‘s Division of Cardiovascular Devices at the Center for Devices and Radiological Health, in the announcement.
Approval was based on positive COAPT trial results first reported at the Transcatheter Cardiovascular Therapeutics conference last fall. In this 614-person trial, heart failure hospitalizations over 24 months were almost halved with MitraClip placement compared with medical therapy alone.
Notably, COAPT results differed from those of MITRA-FR, a French trial released around the same time that did not show benefits to mitral repair in terms of hard outcomes.
Further analyses from COAPT, including quality-of-life findings, are expected at the American College of Cardiology meeting in New Orleans this weekend.