FDA questioned on ProDisc
This article was originally published in The Gray Sheet
Executive Summary
University of California, Irvine spine surgeon, Charles Rosen, MD, sent a letter to CDRH Jan. 20 asking that an advisory panel be convened to assess the safety of Synthes' ProDisc lumbar artificial disc. His request stems from concerns about "the questionable results, and even dangerous consequences" of J&J/DePuy's Charité disc - the only artificial disc approved by FDA to date - including the quality of the study submitted to FDA, lack of information on adverse events and the implant's minimal ability to absorb shock. Synthes announced that ProDisc received an "approvable" letter from the agency Jan. 9. Prompted by a separate physician request, CMS is reviewing whether artificial lumbar discs should be nationally non-covered for Medicare beneficiaries (1"The Gray Sheet" Aug. 22, 2005, p. 3). The agency is expected to release a proposed decision memo Feb. 16...
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