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Biophan Tests MRI-Safe Photonic Pacemaker

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ROCHESTER, N.Y., Feb. 7 -- A temporary photonic pacemaker has been shown to effectively pace a heart by Biophan Technologies Inc. in a test conducted on the manufacturer's behalf by the Greatbatch Enterprises Corp., in conjunction with Downstate Medical Center.

This demonstration of the photonic temporary pacemaker, combined with earlier safety studies, demonstrates the clinical efficacy and safety of one of Biophan's technologies designed to make medical implantable devices, such as pacemakers, compatible and safe to use in patients undergoing magnetic resonance imaging (MRI) exams.

Biophan said it replaced a metallic conductor that is used in pacemakers and other implanted metallic devices with a fiber optic cable, eliminating the causes of problems that resulted in a 1997 FDA ruling prohibited pacemaker recipients from undergoing MRI exams.

Michael Weiner, CEO of Biophan, said the company plans discussions with the FDA about additional requirements for marketing the technology.

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Feb 2003
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