Temporary Artificial Heart to Face FDA Panel Review

An artificial heart for patients too ill to wait for a real transplant could get the go-ahead from a U.S. Food and Drug Administration panel on Wednesday, opening the way for possible approval from the FDA.

An artificial heart for patients too ill to wait for a real transplant could get the go-ahead from a U.S. Food and Drug Administration panel on Wednesday, opening the way for possible approval from the FDA. The agency usually follows its panel’s advice and if the FDA approves the device — called the CardioWest Total Artificial Heart — it would be the first artificial heart on the market. Privately-held SynCardia Systems is seeking approval to use the CardioWest heart as a temporary fix before transplants for the most ill patients with less than 30 days to live. “Having a device like this will provide … a net to catch the patients who are in danger of dying, allowing them to be stabilized,” SynCardia President and CEO Dr. Marvin Slepian said in an interview. There is no cure for heart failure, a slow-developing condition where the heart gradually loses its ability to pump blood. It affects mostly older persons and blacks. Medication and lifestyle changes are initially used to treat the disease, which the National Institutes of Health says affects about 5 million Americans. Another 550,000 are diagnosed annually. A fraction of patients — about 2,300 — receive a transplant each year. In more severe cases, mechanical pumps called ventricle assist devices are used to help pump blood. While two ventricle assist devices can be used at once, Slepian said the CardioWest — which replaces both ventricles — offers lower blood clot risk and better pumping rhythm. A shortage of organ donations can stretch the waiting time for a heart to a year or longer. In the meantime, vital organs can suffer damage or shut down from a lack of blood. Instead of temporary hearts, “what we need is a heart that works on its own,” said Timothy Gardner, a heart surgeon at the University of Pennsylvania in Philadelphia and not involved with the trials. Medical device maker Abiomed Inc. is currently seeking FDA approval for its self-contained, implantable artificial heart called AbioCor. The company has said it hopes to get approval by the second half of this year.Unlike the AbioCor, SynCardia’s device requires a large computerized console to regulate blood flow and must be used in hospitals. Slepian said the company is working on a more portable version. “We do see this as potentially a stepping stone to a … permanent implant in the future,” he said. In a U.S. clinical trial of 130 patients, 81 — mostly men — received the device. Another 35 treated at places where the heart was not available served as a control group. Forty-six percent did not live long enough for a transplant compared with 79 percent with the device. (Source: Reuters Health News: March 2004)