New Artificial Heart Developed as Bridge-to-Transplant

The Circulatory Systems Devices Panel of the U.S. Food and Drug Administration (FDA) has recommended that the heart be approved, with conditions.

The new device offers full circulatory support, the shortest blood path and exposure to artificial surfaces, and the highest level of cardiac output when compared to other previously tested artificial hearts. Called CardioWest TAH, the device is made of plastic and is currently available only on an experimental basis at transplant centers. It is powered by air, pumped from a console outside the body through a tube into the abdomen. CardioWest TAH was developed by SynCardia Systems (Tucson, AZ, USA). The conditions imposed by the FDA panel are a postmarket surveillance of patients and of surgeries needing to occur at heart transplant centers, and more detail on the labeling.

"The panel's positive recommendation means that the CardioWest TAH is on course to become the world's first FDA-approved total artificial heart, making it a viable option for the many seriously ill patients with nonreversible heart disease who are awaiting heart transplants,” said Dr. Marvin Slepian, president and CEO of SynCardia.

With the CardioWest TAH, patients become better candidates for eventual transplantation and have post-transplant survival rates equal to that of nondevice cardiac recipients, studies have shown.




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