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J&J/DePuy Charite

This article was originally published in The Gray Sheet

Executive Summary

Artificial spinal disc is on track for a U.S. debut in the first half of 2005 after J&J/DePuy's submission of a PMA application for the first-of-its-kind device Feb. 9. The filing includes data from a 375-patient, 15-center trial with two-year follow-up on 90% of patients. The study aimed to demonstrate equivalency to traditional spinal fusion. However, the firm claims that in many cases patients achieved superior outcomes with the artificial disc. J&J acquired the technology from Link Spine Group in May 2003 (1"The Gray Sheet" May 12, 2003, p. 22)...
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