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No. R - 1 4 2 FOR IMMEDIATE RELEASE ALC LICENSES CLINICAL TRIALS BOXNO -B-)O3-3 13 1dq,37,y-H ‘JU’I’TH NEW TYPE OF NUCLEAR PACEMAKER ine Ammic t ne rgy Commission has licensed two hospitals to undertake limited clinical trials inpatients of a new nuclear powered heart pacemaker manufactured by AP.CO Nuclear Licenses were issued to Newark Beth Israel fi ospital, Yewark, New Jersey, and to the National Heart and Lung Institute of theh ‘ at ional Institutes of i teal th,Bethesda, Yar yl and. The license applications indicated that the Newark n ospital expects to implant15nuclear pacers in patients and that NILi expects to implant five. The devices previously nave been tested in animals. The ARC0pacemaker,which was developed under a contract with the AEC, is the second type of nuclear powered pacemaker to be approved for clinical testing in the United licensed to implant, on an experimental basis,nuclear pace - makers manufactured by Med tronic s,Inc. The Med tronic s pacemaker uses a plutonium - 258 power source developed in France. About 20 have been implanted inpatients in the ‘[he use of nuclear pacemakers is being licensed on an experimental basis only.Widespread use will not be authorized until information provided by clinical trials can be evaluated. A pacemaker is asti mul at or which helps to regulate the beat of a diseased or damaged heart.Pacers using chemical batteries, which last about two years,have been in use for Nuclear pacemakers use a radioactive source,in this case plutonium - 238,as fuel and are designed to last ten years.If they prove to be effective,their primary advantage would be to reduce the need for frequent surgery t o replace worn out batteries.
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Su clear pacemakers must be built to withstand high speed impact,crushing and extreme heats which may b e associated with accidents without releasing their radio - Implant of nuclear pacemakers canbe made only after the patient has been fully informed of the experimental nature of the device and has given his consent.Provisions must also be made for recovering the pacemaker in case of Under the provisions of the AEC license the hospitals must make periodic examinations of the patient and must gather and report certain required information on a regular the associated back - u p inforrna tion provided with them, were reviewed in detail by the AEC licensing staff with the assistance of a panel of expert consultants consisting of two cardiologists,a surgeon a medical pl lys ici stand two engineers,before the license was issued.