Abiomed to Test Smaller Artificial Heart in 2004
The maker of the self-contained artificial heart that has so far been implanted in five patients said on Wednesday it expects to test a smaller version of the heart in 2004, one that could be used in all adult patients.
The company’s AbioCor replacement heart is currently about the size of a grapefruit and fits into only about 50% of adult males and 18% of adult females. “This smaller device will address the entire ÄadultÅ population,” Abiomed chief executive David Lederman said.
The firm said the design of the original device would be modified by removing an unnecessary component that might be linked to complications such as stroke. There is some indication, Abiomed said, that when the heart tissue is in direct contact with this particular component, deposits form and could cause complications.
“We cannot definitively tie complications to it, but it’s the only element of the system which has raised the possibility,” Abiomed spokesman Edward Berger said. “It’s prudent to remove it. It’s a very minor manufacturing change.”
Stifel Nicolaus & Co. analyst Chris Sergeant said he expected speedy trials and approval of the smaller version of the artifical heart since it is not the functionality of the device that will change, just the size.
The US Food and Drug Administration authorized Abiomed to implant the original plastic and titanium replacement heart in 15 patients.
Of the five patients who have received the implant, three are still alive. One patient who received an AbioCor on November 5 was discharged from the hospital 70 days after the surgery. The other two patients remain stable more than 100 days after the procedure.
Of those who died, a 74-year-old man whose identity was not made public, developed multiple organ failure 56 days after receiving the implant, while the first recipient of the AbioCor, Robert Tools, 59, died from anticoagulation-related problems 151 days after receiving the replacement heart. A sixth patient did not survive surgery.
The Danvers, Massachusetts-based company has said its device, the result of more than 30 years of research incorporating 10 different devices into one, was not to blame for the deaths.
