Abbott (NYSE:ABT) said it’s planning an immediate launch in the U.S. for its MitraClip device now that the FDA has granted a long-awaited pre-market approval for the device, which is designed to treat mitral valve regurgitation.
The approval is for patients with significant symptomatic degenerative MR who can’t have surgery to repair the valve, Abbott said.
The PMA nod follows an FDA advisory panel’s narrow recommendation last March that the federal watchdog agency approve the device. The FDA’s Circulatory System Devices panel voted 8-0 that the MitraClip implant proved safe in clinical trials and 5-3 that the device’s benefits outweigh its risks. The panel was evenly split 4-4 on the question of effectiveness, prompting a tie-breaking opinion from the panel chair, who voted that the available data did not demonstrate effectiveness for MitraClip.
"FDA approval of MitraClip marks an important milestone for Abbott as we continue to bring forward innovative therapies to help patients live better lives," vascular senior vice president Chuck Foltz said in prepared remarks. "We look forward to making this technology available to specialized centers in the U.S. with multi-disciplinary teams experienced in the management of patients with heart valve disease, a model that facilitates dialogue across physician specialties and provides patients with the best treatment outcomes."
The MitraClip device is designed to be delivered using a catheter that’s threaded to the heart via the femoral vein. Abbott said the MitraClip device is still being investigated in a pair of clinical trials, the Coapt study in the U.S. and the Reshape-HF study in Europe.
"The studies also will generate important clinical and economic data that may support development of treatment guidelines, expanded indications and reimbursement. Both studies are currently enrolling patients," according to a press release.
