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AEC ISSUES LICENSE TO NEW YORK HOSPITAL TO IMPLANT NUCLEAR CARDIAC PACEMAKERS IN HUMANS The Atomic Energy Commission has issued a license to the Veterans Administration Hospital in Buffalo, New York, authorizing implant of nuclear powered cardiac pacemakers for clinical evaluation inpatients. The hospital requested authorization to experimentally implant several nuclear powered pacemakers in humans t o determine their usefulness as along life prosthetic device and to identify any problems that may be involved in management and follow - u p of patients bearing the nuclear - powered pacemakers. In the license application,hospital officials indicated tn at as many as ten pacemakers would be implanted within six months following issuance of the license. The pacemaker utilizes electronic circuitry virtually identical to that used in conventionally powered units that have been successfully implanted in tens of thousands of patients in the past. The unique component of the nuclear powered pacemaker is its plutonium - 238fueled thermo - electric power supply which in this case was manufactured by the Society Alcatel of France and the French AEC. Clinical evaluation may require ten years - - the antic i - pate d useful life of the pacemaker. However, tangible results are expected in three to five years, and reports will be made tothe Commission atsix - month intervals or sooner if justified on the basis of developments within the program.
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Implant of the pacemaker will be accomplished on an informed consent basis and will include provision for recovery ofthe pacemaker should death occur. Each patient will be examined and tested periodically on a regular schedule. The unit, which has been successfully implanted in some 20 patients in Europe since April1970,has been designed to withstand stresses associated with impact, crush and fire which may result from accidents. Information submitted by thc applicant and by the pacemaker manufacturer - - h led tronic,Inc.,of lil in neapolis, N innes ota - - was evaluated by the AEC with the assistance of a panel of expert consultants consisting of two cardiologists, a surgeon,a medical physicist and two engineers,before the license was issued.