FDA Approves First Totally Implanted, Permanent Artificial Heart

Statements from National Heart, Lung, and Blood Institute Director Elizabeth, G. Nabel, M.D. and National Institutes of Health Director Elias A. Zerhouni, M.D.

Dr. Nabel:

Today the U.S. Food and Drug Administration approved the first totally implanted artificial heart for patients with advanced heart failure in both of the heart?s pumping chambers. The device is intended for patients who are not eligible for a heart transplant and whose life expectancy without the device is only a month. Heart failure is a serious condition in which the heart is unable to pump enough blood throughout the body. About 5 million people in the United States have heart failure and it contributes to or causes about 300,000 deaths every year.

The approval of the totally implanted artificial heart is a significant milestone as there are few options for heart failure patients with the most severe form of the disease and who are in critical need.

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health is proud to have supported the research which led to this development. Since the 1960s, NHLBI has funded extensive basic research to develop a range of mechanical heart support devices, including the total artificial heart and ventricular assist devices (VADs). This research has led to the development of the devices in use today, which are smaller, more durable, and biocompatible than early models. Among the key clinical studies conducted was an NHLBI-supported trial of left ventricular assist devices in patients with end stage-heart failure (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure or REMATCH). REMATCH was an important step along the way toward the development of the total artificial heart — providing data on both the benefits and problems associated with long term mechanical support.

The totally implanted artificial heart is the culmination of years of research and testing to establish reliability, performance, and safety. It has been the life?s work of teams of scientists, engineers, and designers. And now for the patients who qualify for this device, it can mean longer life — and a better quality of life.

Dr. Zerhouni:

For over half a century, scientists and engineers have dreamed of a total artificial heart. The National Heart, Lung, and Blood Institute?s long-term commitment to this technology has helped to make this dream a reality. It is an example of an NIH institute supporting the development of a medical device that has great public impact — from basic research through preclinical testing and on to clinical readiness. The total artificial heart will extend and improve the quality of life for patients who have no other treatment option.

This also accomplishment demonstrates the kind of long term interdisciplinary scientific efforts needed to address increasingly complex health challenges that often seem initially insurmountable to many. This could not have happened without the patient and far sighted leadership of NHLBI and NIH over several decades.

From NIH

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