FDA Adopts New Artificial Heart Rules : Complications Among 4 Jarvik-7 Patients Lead to Restrictions
Artificial heart implants can continue, but only with case-by-case government approval and under new monitoring and reporting restrictions, the Food and Drug Administration said today.
The FDA adopted the recommendations of a government advisory panel which last month proposed that new restrictions be imposed because of a history of strokes and complications among the four patients who have received artificial hearts.
The agency said it has advised Symbion Inc. of Salt Lake City, manufacturer of the Jarvik-7 artificial heart, of the new requirements. New research guidelines are being drafted and must be approved by the FDA before the next implant of an artificial heart.
The new restrictions include reports every three months on each patient receiving the Jarvik-7 as a permanent replacement heart and FDA approval for each operation, based on the success of the previous operation.
‘Bridge’ Implants Unaffected
The new rules apply only to permanent artificial heart implants, not to so-called “bridge” implants intended to temporarily replace irreparably damaged hearts until a natural heart for transplant can be found.
The full-sized Jarvik-7 is authorized for use as a bridge implant at three U.S. medical centers, and the new regulations do not apply to that use.
But in a related move, the FDA advised Symbion that no further bridge implants of a smaller version of the Jarvik-7 heart can be attempted, even in life-threatening emergencies, until the agency can review data on the smaller heart and approve human testing of the device.
The smaller version is still experimental because of a lack of data on how its 30% smaller size affects blood flow and whether the change might damage blood elements, the FDA said.
1st Female Recipient
The smaller heart was used in an emergency implant in Minneapolis last month in which Mary Lund, 40, of Kensington, Minn., became the world’s first female recipient of an artificial heart.
The FDA said that it approved that implant but that Symbion must apply for and receive approval before attempting a second emergency use.
The FDA four years ago authorized Dr. William DeVries to implant seven permanent Jarvik-7 hearts. He has completed four operations--on Barney Clark, in December, 1982; William J. Schroeder in November, 1984; Murray P. Haydon in February, 1985, and Jack C. Burcham in April, 1985.
Clark and Burcham have died, Burcham after only 10 days. Schroeder and Haydon are alive but have suffered serious complications, including debilitating strokes and internal bleeding and clotting.
