1. Medtech Insight

New Products In Brief

Recent debuts include NuVasive’s PCM cervical disk system, Boston Scientific’s bioabsorbable Synergy drug-eluting stent in Europe and Medtronic’s MRI-safe Advisa pacemaker in Japan.

FDA granted PMA approval to NuVasive Inc.’sPCM cervical disc system, the firm announced Oct. 26. Indicated for use in skeletally mature patients for reconstruction of a degenerative cervical disc, the disc is implanted using an anterior approach. FDA approval comes after successful completion of a prospective, multicenter randomized clinical trial that was conducted at 23 investigational sites across the U.S. and included 403 total treated patients. Composed of cobalt-chrome endplates and a central polyethylene core, the device “features a wide footprint to take advantage of the most stable portions of patients’ cervical vertebral bodies and offers three different footprint and height options,” according to the company. Major competitors in the space include Medtronic, DePuy, Stryker and Synthes.

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