Abbott

(NYSE: ABT)
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announced today that the FDA has approved a label change for its HeartMate 3 left ventricular assist system (LVAD).

The expanded indication removes aspirin from routine patient care. This update applies exclusively to patients with a HeartMate 3 pump and is also approved in Canada and Europe.

HeartMate 3 helps the heart pump blood when it is no longer able to pump blood effectively on its own. The devices work by mimicking the pumping function of the left ventricle. The devices divert blood from the weakened left ventricle and move it into the body’s main artery to help circulate blood throughout the body.

In the past, patients with LVADs used blood thinners to reduce the risk of blood clots related to the device. The ARIES-HM3 study showed that patients who received an Abbott pump but did not take aspirin as part of their blood-thinning medication regimen had nearly 40% fewer bleeding complications without an increased risk of blood clot formation than patients who received HeartMate 3 but took aspirin.

ARIES-HM3 also found that patients who did not take aspirin after implantation spent fewer days in the hospital than patients who took aspirin daily.

“Removing aspirin from the HeartMate 3 medication plan is a simple change that means people with an Abbott LVAD can focus on the things they love and spend less time worrying about and caring for bleeding,” said Keith Boettiger, vice president of the Heart Failure business unit at Abbott. “Through research like the ARIES-HM3 trial, we continue to rewrite the way patients with advanced heart failure are treated and focused on providing life-enhancing benefits to people who rely on our devices to survive.”

A plus for the Abbott HeartMate 3 pump

Numerous issues have contributed to hurdles in the introduction of LVADs and have posed a challenge since their introduction to the market.

Abbott has previously published research showing that HeartMate 3 can extend the lives of patients with advanced heart failure by at least five years. However, Abbott estimates that there are 15,000 patients with advanced heart failure in the United States who are treated with inotropic therapies alone. Their estimated median life expectancy is less than one year.

Eliminating aspirin eliminates one of the barriers to acceptance, says Mandeep R. Mehra, MD, executive director of the Center for Advanced Heart Disease and William Harvey Distinguished Chair at Brigham and Women’s Hospital in Boston, MA, and principal investigator of the ARIES-HM3 trial.

“Aspirin has traditionally been prescribed with warfarin for patients with advanced heart failure and an LVAD, but whether it contributes to excessive bleeding is unclear. The ARIES-HM3 trial, which removed aspirin from the medication schedule, provided important data that challenge the assumption that patients with a heart pump need to take aspirin daily,” Mehra said. “With this label change, physicians can avoid using aspirin in patients with a HeartMate 3 LVAD. This is a safe decision and will reduce bleeding and associated hospital visits.”

However, Abbott recently had problems with its HeartMate 3. Earlier this year, the company initiated a Class I recall for its LVAD’s implant kit. That recall – a correction, not a product withdrawal – resulted in two related deaths. It also followed another Class I recall for some HeartMate II and HeartMate 3 systems in 2023.

Abbott’s HeartMate pumps are currently the only LVADs available in the U.S. market. Medtronic stopped selling its HVAD in June 2021 due to increasing issues with the platform.