The Food and Drug Administration approved the first temporary artificial heart for use in patients at risk of dying as they await a heart transplant, device manufacturer SynCardia Systems announced Monday.
The CardioWest Total Artificial Heart takes over for the patient's failing heart, restoring normal blood pressure and shoring up such organs as the kidney and liver. The bridge device, manufactured by the Tucson, Ariz.-based company, helps keep patients alive long enough for the eventual heart transplant.
An FDA advisory committee in March recommended that the agency approve the device, with caution, since the complex surgery to install the device raises the potential for such complications as infection, bleeding and stroke.
Despite those risks, the panel found the device to have benefits for a small number of patients with no other choice.
Dr. Marvin J. Slepian, SynCardia president and chief executive office, said in a prepared statement that the agency approval represents a "significant milestone in medical history."
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