February 2, 2015 by Val Kennedy
Johnson & Johnson’s DePuy Synthes Spine unit wins expanded FDA clearance for its Synapse screw-rod posterior fixation system, designed to help stabilize the spine following fusion surgery or treatment for certain spinal tumors.
Johnson & Johnson‘s (NYSE:JNJ) DePuy Synthes Spine division said it won an expanded indication from the FDA for its Synapse screw-rod posterior fixation system, designed to help stabilize the spine following fusion surgery or treatment for certain spinal tumors.
Under the expanded approval, the Synapse occipital-cervical-thoracic system can now be marketed with posterior cervical screws, which the 75-year-old practice of internal cervical fixation has evolved to encompass, according to a press release.
“This expanded indication is significant in that DePuy Synthes Spine is now able to sponsor education on the technique and contribute to a greater understanding of its use in treating conditions of the cervical spine,” DePuy Synthes franchise unit leader Karen Rowley said in prepared remarks. “As a company, we continue to pioneer new techniques, expand our portfolio of comprehensive solutions and provide industry leadership in education, research and innovation.”
The Synapse OCT system also includes the Synapse, OC Fusion and Axon device and can be used with the DePuy Expendium spine system, according to the release.
