NuVasive’s Cervical Disc Approved (Orthopedics This Week)
The FDA is raining PMAs (Premarket Approval) on the cervical spine industry.
NuVasive Inc.'s PCM Cervical Disc System has joined Globus's Secure-C and Paradigm Spine's Coflex in receiving recent approvals from the FDA. The company announced the approval on October 26 during the annual meeting of the North American Spine Society.
NuVasive acquired the PCM when it acquired Cervitech in 2009 for up to $80 million. The company, according to Wells Fargo's analyst Larry Biegelsen, has previously stated it anticipates the product can generate close to $200 million of the life of the product. The market is currently dominated by DePuy/Synthes and Medtronic.
Alex Lukianov, the company's chairman and CEO, said the PCM Cervical Disc is a "game changing solution" for the cervical spine. "This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices. Its low-profile design enables it to be minimally disruptive to the adjacent anatomy and a viable treatment option for levels adjacent to prior fusions."
The company's regulatory and clinical affairs vice presiden...
