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Raymedica disc update

This article was originally published in The Gray Sheet

Executive Summary

Investigational device exemption for the PDN-Solo pivotal trial is pushed back to June, due to a longer-than-expected pilot study. With patient enrollment now scheduled to start by the end of Q4, the firm anticipates receiving PMA approval in 2007, rather than the second half of 2006. The prosthetic disc nucleus device, which previously was priced in comparison to spinal fusion at $4,000, now will be priced in line with other artificial discs at $6,000 and will fall under the new CPT code for spinal arthrodesis, expected in the spring. The company anticipates selling up to 360,000 devices upon release (1"The Gray Sheet" Oct. 27, 2003, p. 25)...
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