- Abbott said its HeartMate 3 left ventricular assist device (LVAD) received FDA approval as a permanent implant for people with advanced heart failure who are ineligible for a transplant, meaning patients can live with the device for the rest of their lives.
- The approval of the mechanical pump as a destination therapy was supported by data from the Momentum 3 clinical trial that showed a survival rate of 82.8% at two years and rates of 1.1% for blood clots and 10% for stroke, the company said.
- The HeartMate 3 is smaller in size than previous generations of the device and incorporates technology called fully magnetically levitated flow that is designed to reduce trauma to the blood passing through the pump.
An LVAD differs from an artificial heart in that the device assists the patient's own heart rather than replacing it. Traditionally used as a bridge to transplantation, LVADs have become a viable permanent alternative to a heart transplant as the technology has advanced.
More than 25,000 heart failure patients have received a HeartMate II LVAD, with some having passed a 10-year milestone living with the device, according to Abbott.
Abbott’s HeartMate 3, approved in 2017 for short-term support of patients waiting for a donor heart, is the third generation of the device that the company acquired through its $25 billion acquisition last year of St. Jude Medical. The heart pump was originally developed by Thoratec, which St. Jude bought for $3.4 billion in 2015.
Data from the Momentum 3 study, presented earlier this year at the American College of Cardiology annual meeting, showed none of the HeartMate 3 patients had a pump-related blood clot requiring reoperation, compared with 12.2 percent of HeartMate II patients. HeartMate 3 patients had fewer strokes of any kind at 89.9%, compared with 80.8% for HeartMate II patients, according to the study, which was also published in the New England Journal of Medicine.
The 82.8% survival rate at two years for HeartMate 3 patients compared with 76.2% for the HeartMate II group. Freedom from disabling strokes was similar in both groups at 92.8% for HeartMate 3 and 92.5% for HeartMate II.
Analysts have said the Momentum 3 results could help Abbott gain market share from competitor Medtronic's ventricular assist device called HeartWare, acquired in 2016. The HeartWare system gained FDA approval as a bridge-to-transplant device in 2012 and as a destination therapy in 2017.