NuVasive has gained premarket approval (PMA) for its cervical motion preserving system from the US Food and Drug Administration (FDA).
The PCM cervical disc device, which is comprised of superior and inferior endplates, is designed for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7.
The system features broad radius of central polyethylene core which allows for unconstrained motion preservation and a broad radius of articulation allows for coupled motion.
NuVasive chairman and chief executive officer Alex Lukianov said with the launch, the company is offering the new technology to the US surgical and patient community.
"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," Lukianov added.
The PMA application included positive data of 403-patient based prospective, multicenter randomized investigational device exemption clinical trial.
NuVasive regulatory and clinical affairs vice president Laetitia Cousin said the data speaks about 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 recognized journals," Cousin added.
"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."
