The University of Arizona is among institutions negotiating with Symbion Inc. to take over manufacturing artificial hearts once the company goes out of business.
Symbion, based in Tempe, said earlier this month it lost more than $1 million last year and wants to dissolve as a corporation.Symbion was founded shortly after a University of Utah medical team made history by implanting the first artificial heart in a human in December 1983.
Dr. Robert Jarvik, developer of the Jarvik-7 artificial heart, and other researchers from the university, were among the original owners and officers of the company.
However, as they are making plans to dissolve the business, Symbion officials are negotiating to transfer the technology of making artificial hearts.
"We are looking for an institution, such as a research-oriented university, that will take this over and hopefully allow the technology to continue to be available," said Lane Castleton, Symbion's chief financial officer.
He declined to identify the institutions, but a University of Arizona official confirmed that the school is one of them.
"We expect a decision on this to come down in short period of time," said Jack G. Copeland, the head of University Medical Center's heart transplant team.
"If it happens, we would take upon ourselves the burden of proof for the FDA that these devices are still worthy of investigation, that studies using them should be reopened," Copeland said this week.
"It could also mean that the UA will take over the actual manufacture of the devices, at least for the short term, until we could find an industry willing to do it for us."
The Food and Drug Administration in January 1990 withdrew approval for Symbion's Total Artificial Heart and its Acute Ventricular Assist Device, preventing Symbion from marketing the devices in the United States.
At that time, the FDA criticized Symbion for poor quality control, poor monitoring of the use of its devices in research centers, failure to document negative patient results and problems in training people to use the devices.
The assist device is a mechanical "half-heart" that assists a failing heart but does not require removal of the natural heart as does the Jarvik-7.
Company President Richard W. Alder said earlier this month that Symbion did not think it would succeed in obtaining renewed approval.
"The main reason for this decision (to dissolve the corporation) is our problems with the FDA," Castleton said. "We see no way out of it anymore."
UMC has used the Jarvik-7 artificial heart in eight dying patients, keeping four of them alive until they underwent human heart transplants. Heart-assist devices have been used more than a dozen times at UMC to sustain patients during the past two years.