Norian
This article was originally published in The Gray Sheet
Executive Summary
Company's SRS cement is more appropriately classified as an "internal fixation device" rather than a "bone void filler," as was reported in the Jan. 4 issue of "The Gray Sheet" (p. 15), since it is resorbed in vivo, rather than dissolved, and it offers compressive strength, the company states. Norian's trial treated 75 intra-articular fractures, and only four patients reported adverse events, leading FDA to decide that long-term follow-up on those cases would be inconclusive. Norian also clarifies that the difference in average radial length loss between SRS and control patients was not statistically significant