FDA Panel Rejects Implantable Artificial Heart
FDA Panel Rejects Implantable Artificial Heart
Experts Debate Quality of Life for Patients With AbioCor Artificial Heart
June 23, 2005 -- An advisory panel narrowly voted against recommending FDA approval of the first fully implantable artificial heart. Panel members could not agree on whether its benefits outweighed its risks for desperately ill patients.
Experts toiled over whether to recommend FDA approval of the AbioCor artificial implantable heart. The device is intended to prolong the lives of patients at risk of imminent death from heart failure, but who are too sick to withstand natural heart transplantation.
The heart replacement device is totally implanted in the body and is intended to help patients remain mobile. Other forms of artificial heart devices are attached to large units and connected by various wires and tubes.
Twelve patients who received the artificial implanted heart survived an average of 5.3 months after surgery. These patients would have been expected to die of heart failure within 30 days or less without treatment. Two others patients died in the operating room during the procedure.
One patient, a 51-year-old man, lived for nearly a year and a half with his heart replacement. He was shown on company videos exercising on a stationary bicycle and lifting weights. But six others who survived, often more than four months, did so without ever being able to leave the hospital. One patient lived for 53 days but was never conscious.
Experts struggled to decide if the longer life delivered by the artificial heart implant was worth the risks. Three-quarters of patients sustained multiple debilitating strokes after surgery, calling into question the quality of the extra time they'd received from the device.
Panelists cast three votes on whether to approve AbioCor under an FDA humanitarian program reserved for products intended for only a handful of patients. Two votes on approving the device failed by a single vote, while another urging rejection also failed by the same margin.
The committee ultimately retreated to a technical vote on whether AbioCor met FDA's regulatory definition of a humanitarian device whose probable benefits outweighed its potential risks. They voted 7 to 6 that it did not, with one member abstaining.
FDA Panel Rejects Implantable Artificial Heart
Experts Debate Quality of Life for Patients With AbioCor Artificial Heart
June 23, 2005 -- An advisory panel narrowly voted against recommending FDA approval of the first fully implantable artificial heart. Panel members could not agree on whether its benefits outweighed its risks for desperately ill patients.
Experts toiled over whether to recommend FDA approval of the AbioCor artificial implantable heart. The device is intended to prolong the lives of patients at risk of imminent death from heart failure, but who are too sick to withstand natural heart transplantation.
The heart replacement device is totally implanted in the body and is intended to help patients remain mobile. Other forms of artificial heart devices are attached to large units and connected by various wires and tubes.
Twelve patients who received the artificial implanted heart survived an average of 5.3 months after surgery. These patients would have been expected to die of heart failure within 30 days or less without treatment. Two others patients died in the operating room during the procedure.
One patient, a 51-year-old man, lived for nearly a year and a half with his heart replacement. He was shown on company videos exercising on a stationary bicycle and lifting weights. But six others who survived, often more than four months, did so without ever being able to leave the hospital. One patient lived for 53 days but was never conscious.
Debate Over Quality of Life
Experts struggled to decide if the longer life delivered by the artificial heart implant was worth the risks. Three-quarters of patients sustained multiple debilitating strokes after surgery, calling into question the quality of the extra time they'd received from the device.
Panelists cast three votes on whether to approve AbioCor under an FDA humanitarian program reserved for products intended for only a handful of patients. Two votes on approving the device failed by a single vote, while another urging rejection also failed by the same margin.
The committee ultimately retreated to a technical vote on whether AbioCor met FDA's regulatory definition of a humanitarian device whose probable benefits outweighed its potential risks. They voted 7 to 6 that it did not, with one member abstaining.
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