FDA to Rethink Its Approval of Jarvik-7 Heart
The Food and Drug Administration, concerned about disappointing results with the Jarvik-7 artificial heart, said today that it is considering whether to allow Dr. William DeVries to complete a series of seven implants the agency earlier authorized.
DeVries, based at the Humana Heart Institute of Louisville, Ky., is the only U.S. surgeon licensed to implant permanent artificial blood pumps in humans. Seven Jarvik-7 hearts have been implanted since late 1982, and most of the recipients have suffered strokes blamed on blood clots from the devices.
Two of the five patients who received the artificial hearts on a permanent basis--William J. Schroeder and Murray P. Haydon--are alive, but are disabled to some extent by stroke complications.
To Hear Report
FDA spokesman David Duarte said the agency’s advisory panel will meet Dec. 20 to discuss the artificial heart and a report submitted in September on results of artificial heart implants.
The Boston Globe reported today that Dr. Abhi Acharya, acting director of the FDA’s division of cardiovascular devices, said the advisers will be asked if DeVries should be permitted to complete the series of authorized implants.
“The question is: Are there valid clinical and scientific reasons for doing the other three implants with the present device . . . or is there need for a pause, for a re-evaluation of the whole thing at this point?” Acharya was quoted as saying.
Acharya said DeVries was asked to submit the report “elaborating on all the findings to date” earlier than expected “because of the widely known adverse results.”
Ongoing Surveillance
Duarte said the FDA will “pose those questions to the panel,” made up of non-government physicians and scientists specializing in cardiovascular issues, as part of ongoing surveillance of the artificial heart program.
He denied that there is cause for alarm.
“If we had gotten to the stage where the risks far outweighed the benefits, then the agency would have stopped the clinical trials,” he said.
He said the FDA is also concerned about a lack of uniformity in experiments with temporary artificial hearts, used to keep patients alive until human donor hearts can be found, but plans no public review of the temporary pumps at this time.
