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Stryker OP-1 clarification

This article was originally published in The Gray Sheet

Executive Summary

U.S. approval by 2006 for use of the orthobiologic bone growth factor in posterior lateral spine procedures is expected by the company; enrollment in a 300-patient U.S. pivotal trial is ongoing. OP-1 has been available in the U.S. for recalcitrant long bone, non-union fractures via humanitarian device exemption since 2001; the firm also is pursuing a full long-bone indication. In March, "The Gray Sheet" incorrectly reported that OP-1 was not approved for any indication (1"The Gray Sheet" March 31, 2003, p. 33)...
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