Going From Temp to Perm: It's "Heart" Work

Originally Published MDDI August 2002

NEWS & ANALYSIS

Going From Temp to Perm: It's "Heart" Work

What do heart-failure patients, their doctors, and cardiopulmonary equipment manufacturers have in common? All three hope to see FDA approve the use of implantable heart pumps as permanent alternatives to artificial hearts, heart transplantation, and drug regimens for patients suffering from class-IV heart failure. Such pumps as the Jarvik 2000 and HeartMate have traditionally been used as temporary transitional devices in patients awaiting heart transplants, but a study published recently in Circulation: The Journal of the American Heart Association suggests their potential value as permanently implanted devices.

Known in the medical community as left ventricular assist devices (LVADs), the heart pumps have been used for the past four years to keep patients alive as they wait for heart transplants. In light of the Circulation study, however, FDA must decide whether to approve LVADs for what cardiologists are calling "destination therapy."

Clinical trials of LVADs implanted permanently in patients (in lieu of actual heart transplants) are currently under way both in the United States and abroad. One study, known as REMATCH, is spread across 20 transplant centers and is a collaborative effort of NIH, Columbia University, and Thoratec Corp., manufacturer of HeartMate. It is likely that this trial's outcome will help determine FDA's final decision on marketing LVADs as permanent devices.

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