In-Hospital Artificial Heart Nears Approval
Device Would Be Bridge to Heart Transplant
March 18, 2004 -- An in-hospital artificial heart got a thumbs-up yesterday from an FDA advisory panel.
The CardioWest Total Artificial Heart (TAH) is not intended as a lifelong heart replacement. Instead, it's meant to keep patients at risk of imminent death from heart failure alive until they can get a heart transplant. The device is manufactured by SynCardia Systems Inc., in Tucson, Ariz.
"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 many seriously ill patients with non-reversible heart failure who are awaiting heart transplants," SynCardia CEO Marvin Slepian, MD, says in a news release.
The CardioWest TAH is implanted in a patient's chest, replacing the damaged bottom chambers of the heart. External tubes connect it to a large console in the hospital room. It offers more complete circulatory support -- with less exposure to artificial surfaces -- than existing cardiac support systems.
While the product is described as a "bridge" to a heart transplant, it's intended to make patients become better candidates for eventual heart transplants.
The FDA is not bound by its advisory committee votes, but it almost always follows their recommendations. In this case, the expert panel advised the FDA to approve the CardioWest artificial heart with three main conditions:
- After approval, the company must continue to monitor patients.
- The device can be implanted only at heart transplant centers.
- The device labeling must include greater detail.