The US Food and Drug Administration (FDA) has granted premarket approval (PMA ) to NuVasive ‘s cervical motion preserving device, designed for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7.
The PCM cervical disc comprises superior and inferior endplates featuring three rows of ‘V-Teeth’ to provide short-term fixation until long-term fixation occurs to anchor the device.
In addition, the system’s broad radius of central polyethylene core allows for unconstrained motion preservation and a broad radius of articulation allows for coupled motion.
NuVasive chairman and chief executive officer Alex Lukianov said the company is pleased to be launching the device in the US.
"This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices," Lukianov said.
"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 PMA application included positive data of 403-patient based prospective, multicentre, randomised investigational device exemption clinical trial, designed to assess the safetyand efficacy of the device.
NuVasive regulatory and clinical affairs vice president Laetitia Cousin said the data demonstrates the clinical benefits of the device.
"In keeping with the NuVasive philosophy to promote science and education, our investigators have contributed over 17 peer-reviewed publications on the PCM Cervical Disc in internationally recognised journals," Cousin said.
"I am exceptionally proud of the surgeons, clinical research staff, patients, and dedicated NuVasive shareowners that contributed to the advancement of science through the IDE trial and helped to bring this device to market."