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FDA Clears HeartMate 3 Pump for HF Destination Therapy

The US Food and Drug Administration has approved the HeartMate 3 left ventricular assist system (Abbott) as a long-term destination therapy for patients with advanced heart failure who are ineligible for heart transplant.

The HeartMate3 system received FDA approval for patients with HF requiring short-term hemodynamic support in August 2017 and CE mark in Europe for both short- and long-term support in October 2015.

US approval of the device as a bridge to transplant was supported by 6-month results of the MOMENTUM-3 trial, comparing the HeartMate 3 pump with Abbott’s older-generation HeartMate II pump, already marketed for destination therapy in patients with advanced HF.

Support for the new indication was provided by recently reported 2-year results from the trial, showing that the HeartMate 3 bested its older sister for the end points of survival (82.8% vs 76.2%), freedom from reoperation or pump removal (97.2% vs 75.5%), and freedom from stroke (89.1% vs 76.3%) in patients with severe HF (New York Heart Association class IIIB or IV).

Rates of suspected pump thrombosis remained very low, at 1.1%, and the stroke rate was the “lowest-ever published stroke rate (10 percent) for a continuous-flow LVAD at two years,” according to a company news 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 therapystroke and blood clotting — while also offering survival rates on par with transplant,” Nir Uriel, MD, director of Heart Failure, Transplant and Mechanical Circulatory Support, University of Chicago Medicine, said in the release.

The HeartMate 3 system consists of the LVAD pump and components that help power and monitor the technology, including an external, wearable controller and battery system.

This spring, the FDA issued a class I recall for HeartMate 3 devices after it was determined that problems with its outflow graft assembly may lead to graft occlusion. The company has retrained surgeons on proper implant technique and subsequently received FDA approval for the Outflow Graft Clip, which was designed to mitigate outflow graft twisting, an Abbott spokesperson told theheart.org | Medscape Cardiology.

Abbott. October 19, 2018

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