FDA clears NuVasive's latest spine surgery system

X-ray of cervical spine
NuVasive's CoRoent Small Interbody System may be used with five different CoRoent implants.

NuVasive picked up an FDA nod for its spinal implant system for the treatment of cervical disc degeneration. It is the first cervical cage system cleared for treating up to four contiguous levels of the spine.

More than 200,000 procedures on the cervical spine are conducted in the U.S. each year. Cervical radiculopathy and myelopathy—the compression of nerves that can cause pain, numbness and weakness—can lead to disability and are common diagnoses in adult patients.

The NuVasive CoRoent Small Interbody System is indicated for fusion of vertebral bodies—the main portion of each vertebra—at multiple adjacent levels in the cervical spine, the company said in a statement. During a procedure, the system stabilizes the part of the spine being fused. Each end of the device has rows of teeth, which grip the adjacent vertebrae to prevent migration.

“The ability to treat multilevel cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons," said Jason Hannon, NuVasive chief operating officer, in the statement. "This first and only clearance is an example of NuVasive's commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market."

In January last year, NuVasive entered the scoliosis market with its $380 million acquisition of Ellipse Technologies. In the deal, it picked up the MAGnetic External Control (MAGEC) Spinal Bracing and Distraction System, which is cleared in the U.S. for patients under the age of 10.

Read more on

Suggested Articles

Janssen is planning its first completely virtual clinical trial, using personal smartphones and wearable devices with no in-person site visits.

Sensyne Health aims to bring its AI tools to America, and it’s enlisting IT giant Cognizant and data infrastructure specialist Agorai to help.

Daré Bioscience added a microchip-based implant to its pipeline and reported data from a pre-pivotal study of a hormone-free contraceptive ring.