FDA PMA Approval For NuVasive’s PCM Cervical Disc System

In short

NuVasive, Inc., has reported having a good week at NASS2012, culminating with the news that the U.S. FDA has granted Premarket Approval for the PCM® Cervical Disc System.

Background 

NuVasive describes itself as a medical device company focused on developing minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 4th largest player in the $7.9 billion global spine market.

The PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localised to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The device is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation.

The PCM Cervical Disc is composed of cobalt chrome endplates and a central polyethylene core, materials that have a long and well-studied history of use in other orthopedic joint replacements. The broad radius of the polyethylene core allows for unconstrained motion preservation and a broad radius of articulation for coupled motion. 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. The superior and inferior endplates also feature three rows of “V-Teeth” which provide short-term fixation until long-term fixation can occur to anchor our motion preserving device.

This novel device will be provided to patients and surgeons in the United States as an innovative option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure. The FDA approval comes after successful completion of a prospective, multicentre randomised investigational device exemption (IDE) clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.

Company comments

Alex Lukianov, NuVasive’s Chairman and Chief Executive Officer, said, “We are really pleased to offer this unique technology to the U.S. surgical and patient community. The PCM Cervical Disc is a game changing solution for the cervical spine, and marks our foray into an exciting market. 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.”

Laetitia Cousin, Vice President of Regulatory and Clinical Affairs at NuVasive, said, “The strong clinical data speaks for itself and makes our monumental effort to gain this PMA approval well worth it. 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. 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.”

Regulatory status

The PCM disc is CE marked and has approximately ten years experience in Europe.

Source: NuVasive, Inc.