Lumbar Disc Developers Hold Their Own With Orthopedic Giants
This article was originally published in The Gray Sheet
Executive Summary
Raymedica and Interpore Cross are readying internally-developed artificial spinal disc offerings for U.S. market entry behind J&J/DePuy Acromed, Medtronic/Sofamor Danek and Synthes-Stratec - three companies competing through recent acquisitions
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Atlanta-based Cryolife is preparing for human trials to support approval of its BioDisc spinal disc repair system and plans to file for an FDA investigational device exemption in the first half of 2005
Cryolife Hydrogel Technology Provides Platform For Diverse Pipeline
Atlanta-based Cryolife is preparing for human trials to support approval of its BioDisc spinal disc repair system and plans to file for an FDA investigational device exemption in the first half of 2005
Raymedica disc update
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)...