LVAD now approved as destination therapy

Abbott announced that its newest-generation left ventricular assist device has been approved by the FDA for implantation in patients with advanced HF ineligible for a heart transplant.

The LVAD (HeartMate 3, Abbott), which includes a continuous centrifugal-flow fully magnetically levitated pump engineered to prevent thrombosis, was previously approved in August 2017 as a bridge therapy for patients with advanced HF awaiting a heart transplant, according to a press release from the company.

“Approximately a quarter of a million people are living with advanced heart failure, and many of these people will need a heart transplant; however, only a few thousand will receive a new heart,” Nir Uriel, MD, director of heart failure, transplant and mechanical circulatory support programs at the University of Chicago Medicine, said in the release. “The destination therapy approval for Abbott's HeartMate 3 device now gives these patients new hope that they can receive a heart pump clinically proven to mitigate challenges we've historically confronted with this therapy — stroke and blood clotting — while also offering survival rates on par with transplant.”

Approval for the new indication was based on results of the MOMENTUM 3 study in which, as Cardiology Today previously reported, patients assigned the HeartMate 3 device more often survived free from disabling stroke or reoperation at 2 years compared with those assigned a predecessor device with an axial continuous-flow pump (HeartMate II, Abbott).

Disclosure: Uriel reports he receives research grants from Abbott and Medtronic and honoraria from Abbott.