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FDA approves artificial heart for HF patients
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The FDA approved the first totally implanted artificial heart, AbioCor, for patients with advanced heart failure in both pumping chambers, under the Humanitarian Use Device provisions of the Food, Drug and Cosmetic Act.
Clinical studies showed that AbioCor could prolong life and improve the quality of life for critically ill people who are ineligible for a heart transplant.
AbioCor helps extend life
The AbioCor system includes a 2-lb artificial heart that takes over the pumping function of a diseased heart when it is removed during implantation. It also includes a power transfer coil that recharges the internal battery from the outside, a controller and an internal battery. The controller and battery are implanted in the patient’s abdomen.
The controller monitors and controls function, including the pumping rate, and the internal battery allows patients to be free from external connections for up to one hour. Two external batteries allow the patients to move freely for up to two hours. The system can be plugged into an electrical outlet while the patient sleeps or when batteries are recharging, according to an FDA release. Patients must undergo a screening process to determine if their chest volume is large enough for the device.
Devices approved under Humanitarian Use Device provisions are intended to treat people with conditions or diseases that affect fewer than 4,000 people each year. Only devices with demonstrated safety and efficacy are approved for market under the provisions.
The FDA approved AbioCor based on animal testing and a clinical study that involved 14 patients. The device is likely to benefit people with severe HF, who are facing imminent death or have no alternative treatments. The device extended survival by several months in some cases; however, it extended survival by 10 and 17 months in two cases. One of the patients could be discharged from the hospital, according to the FDA.
The FDA will require Abiomed to provide a comprehensive patient information package that describes possible risks and benefits associated with the device. Although the FDA recognizes that not all eligible patients will choose AbioCor, many patients will choose it to gain additional time with family and friends, said Daniel Schultz, MD, director of the Center for Devices and Radiological Health at the FDA.
Abiomed is conducting additional studies, including a post-marketing study that will involve 25 additional patients.
Rocky road to approval
After multiple votes last year, the FDA’s Circulatory System Devices advisory panel voted 7-6 against recommending the device’s approval. Panel members who voted against the device said that a study with only 14 participants did not provide enough data to determine whether the device would help more patients than it could hurt.
Panelists who voted to recommend the device did not dispute the lack of evidence, but said that they voted in favor of the device because the application was for a Humanitarian Use Device. Other panelists, however, were concerned because no health measures beyond survival were taken into account. Many patients died of complications from stroke caused by poor anticoagulation early in the study.
AbioCor is not the first articial heart to gain FDA approval. SynCardia Systems Inc.’s CardioWest, a temporary, total artificial heart, received the FDA’s first approval for an artificial heart in October 2004, according to a company release. The FDA approved CardioWest as a bridge to transplant for people waiting for a heart who do not respond to other treatments but are at risk for imminent death caused by nonreversible biventricular failure.
For more information:
- Visit the company’s Web site at: www.abiomed.com.