HeartMate 3™ Mechanical Assist Device FDA-Approved
Thanks in large part to the leadership of Columbia’s Cardiac Transplantation and Mechanical Circulatory Support Programs, a new left ventricular assist device, the Heartmate 3™ LVAD is now FDA approved.
“We have received a Short Term indication: bridge to transplant or bridge to myocardial recovery,” says Yoshifumi Naka, MD, PhD, director of these programs, an internationally known heart transplant surgeon and pioneer in circulatory assist devices. “This is an important advance for patients struggling with advanced heart disease.”
On August 28th, the day of FDA approval, Columbia enrolled its 100th patient in the MOMENTUM3 Clinical Trial. Columbia was among the first to offer patients access to Heartmate 3™, the newest LVAD technology, in a trial testing it against current standard of treatment, the Heart Mate II.
In a randomized study reported in New England Journal of Medicine and presented at American Heart Association in November 2016, lead investigator Yoshifumi Naka, MD, PhD, reported fewer complications with the Heartmate 3™ noting a marked improvement over Heartmate II. Dr. Naka, the first author of this landmark paper, is director of Columbia’s Cardiac Transplantation Program and Mechanical Circulatory Support Program, and Columbia enrolled the largest number of patients in this trial.
Columbia’s heart transplant program is also the largest (by volume) in the nation.