FDA approves heart device tested at IMC

MURRAY — The Food and Drug Administration has approved a mechanical device to help patients survive advanced heart failure long enough to receive a transplant.

And Utahns with advanced heart failure are among the first nationally to benefit from the HeartMate II by Thoratec, tested extensively at Intermountain Medical Center as part of a clinical trial.

IMC is one of 44 centers that participated in the study of a new-generation left-ventricular assist system (LVAS) as a bridge to heart transplant. It's the first continuous-flow cardiac assist system approved by the FDA in the United States.

The Utah Artificial Heart Program, which moved to IMC from LDS Hospital when the new hospital opened, has successfully implanted 225 ventricular assist devices in recent years, including 33 of the HeartMate IIs.

The device is implanted alongside a patient's own heart and takes over the pumping ability of the weakened heart's left ventricle. It can pump up to 10 liters of blood a minute, the full output of a healthy heart. Unlike earlier versions, it has only one moving part, so it is expected to last longer and operate more quietly. It's also about one-eighth the size of the original device.

Now, IMC is part of a clinical trial of HeartMate II as a destination therapy, meaning transplant is not the goal for the participants, who would be maintained on the LVAS.