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FDA approves next-generation LVAD

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Mandeep R. Mehra

Abbott announced that the FDA has approved its left ventricular assist device with a continuous-flow magnetically levitated pump for treatment of patients with advanced HF requiring short-term hemodynamic support.

The device, called HeartMate 3, is indicated for patients needing a bridge to transplant or a bridge to myocardial recovery, according to an Abbott press release.

Compared with its predecessor device (HeartMate II), the new LVAD is smaller and employs full magnetic levitation technology designed to reduce trauma to the blood passing through the pump and improve blood flow, per the release.

Approval was based on the MOMENTUM 3 study, in which at 6 months, patients assigned the HeartMate 3 showed an improvement in HF status, increased walk distance by 83%, improved quality of life by 68% and had an 86% rate of survival free from disabling stroke and reoperation for pump replacement, Abbott reported in the release.

“In the MOMENTUM 3 study, the HeartMate 3 system had no instances of suspected or established blood clotting within the pump at 6 months, which is a major milestone for those of us working tirelessly to improve clinical outcomes for patients with advanced [HF],” Mandeep R. Mehra, MD, MB, BS, medical director at Brigham and Women’s Hospital Heart and Vascular Center, said in the release. – by Erik Swain

Disclosure: Mehra reports he received nonfinancial support from St. Jude Medical, now part of Abbott, during the conduct of the MOMENTUM 3 study, and receives personal fees from Janssen Pharmaceuticals, Medtronic, Stealth Biotherapeutics and Teva.