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Clinic finishes enrollment for FDA validation trial

Aug 20, 2011 by staff


Clinic completes enrollment for FDA Validation Trial

Dr Edward Hellman’s spinal surgical practice was selected as one of only 25 centers in the country to participate in an FDA validation trial for a new implant for degenerative disc disease of the lumbar spine known as the Solitaire Implant. Each center was to enroll 20 consecutive patients in the trial and information regarding preoperative, perioperative and postoperative outcome were collected. The enrollment phase has been completed and the data has been submitted and analyzed. “It was an honor to have been selected for the study and I hope the data collected from sites throughout the country will be useful to the FDA and also be used to further the development of new advances in spinal surgery,” states Dr. Hellman

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