Dive Brief:

• Abbott Laboratories shared data on Monday showing patients with advanced heart failure implanted with its HeartMate 3 left ventricular assist device (LVAD) had a better survival rate after five years than patients implanted with its older HeartMate II LVAD.
• The heart pump, which was approved by the Food and Drug Administration in 2017, provides mechanical circulatory support for patients with advanced heart failure.
• In total, the HeartMate 3 had a 58% survival rate during the five-year period, compared to a 44% survival rate for the HeartMate II. The difference was largely because of a reduction in deaths due to stroke, clotting and bleeding with the newer-generation device.

Dive Insight:

Abbott shared the results from its MOMENTUM-3 randomized trial during a late-breaking presentation at the European Society of Cardiology Congress in Barcelona, Spain.

More than 1,000 patients were enrolled in the study, with just over 500 patients randomized to be implanted with the HeartMate 3 or Heartmate II device, according to the presentation. Of patients implanted with the HeartMate 3, a total of 156 died, 156 received a transplant and four had the device removed or deactivated by the end of the five-year period. 

Between the two devices, the HeartMate 3 had a significantly lower rate of deaths due to device thrombosis, stroke or bleeding. Deaths caused by heart failure, infection and other causes were similar between the two devices.

The device was initially approved in 2017 as a stopgap for patients with heart failure who are awaiting a transplant. Later in 2018, it received approval to be used as a permanent implant for people with advanced heart failure who are ineligible for a transplant.

With a 58% five-year survival rate for the HeartMate 3, it’s approaching the five-year survival rates for heart transplant recipients with a similar risk profile, Abbott said in a statement.

"Thousands of people with advanced heart failure die every year because they do not receive a heart pump, largely because their physicians are not aware of the option or its full benefits," Keith Boettiger, vice president of Abbott's heart failure business, said in the statement.

Medtronic pulled its competing LVAD pump, called the HeartWare or HVAD System, from the market in 2021, after multiple recalls and reports of patient deaths. In a June 2021 notice to healthcare providers, the FDA said the company stopped selling the device because of an increased risk of neurological adverse events and mortality associated with the pump and the potential for the internal pump to stop, which may lead to death or serious injuries.

Since it stopped selling the HeartWare pump, Medtronic has faced multiple Class I recalls, including problems with the devices’ batteries, pumps and connector plugs.