FDA panel backs temporary artificial heart

	Tweet

A U.S. Food and Drug Administration panel on Wednesday backed an artificial heart to keep the sickest patients alive while they wait for a transplant.

The CardioWest Total Artificial Heart by SynCardia Systems would be the first on the market if the FDA follows the panel’s 10-1 recommendation. The agency usually agrees with the advice of its expert panels.

The FDA advisers said the CardioWest replacement heart successfully kept patients alive, but should only be used in dire situations because of a high rate of side effects like infection, seizure, stroke and bleeding.

“This is not something any of us would subject ourselves to unless we were dying,” said panelist Judah Weinberger of Columbia University. But, he added, “I think this likely has net benefit to the patient.”

Privately held SynCardia is seeking approval to use the device as a temporary fix before transplants for heart failure patients with less than 30 days to live. Because it requires a large computerized console to regulate blood flow, it can only be used in hospitals.

Five million Americans have failing hearts, and 100,000 are sick enough for a transplant. Only about 2,100 of the 3,800 on the waiting list in 2002 received transplants. Up to a quarter of the patients on the list die while waiting.

Mechanical pumps called left ventricular assist devices can take over, but often can’t maintain full heart function, and 30-40 percent of patients on the devices die before transplant.

The CardioWest heart takes over completely, and is better at maintaining blood pressure and supplying oxygen to organs, said Dr. Marvin Slepian, president and chief executive officer of Tucson, Arizona-based SynCardia.

The committee debated who should get the devices, but most agreed it should be people facing imminent death and who wouldn’t benefit from the left assist devices.

Slepian estimated that several hundred patients per year would receive the device.

The device’s huge costs, $80,000-$100,000 for the heart, plus hospital and surgery expenses, aren’t currently covered by insurance. FDA approval should bring some coverage, Slepian predicted.

Another company, Abiomed Inc., hopes to win FDA approval of its artificial heart called AbioCor by the second half of 2004. Unlike SynCardia’s device, the AbioCor is completely implanted.

RELATED STORIES:
NIH Grants $6.78 Million to Study Progression of Heart Disease   Exercise safe for people with defibrillators   Researchers find link between common dietary fat, intestinal microbes and heart disease   U of T researchers find link between childhood physical abuse and heart disease   Celecoxib Can Adversely Affect Heart Rhythm   Adrenaline shot may not always help heart patients: study   Medtronic device helps in earlier heart failure   Statins seem beneficial during heart attack   Drug combos up survival for heart disease patients   Medtronic voluntarily recalls defibrillators   Complicated link between diet drinks, health: study   Heart remodels itself after coronary treatment

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]