Orthofix receives FDA and CE mark approval for next-generation CervicalStim and SpinalStim

Orthofix’s next-generation SpinalStim and CervicalStim

Orthofix has received both US Food and Drug Administration (FDA) and CE mark approval for its next-generation CervicalStim and SpinalStim bone growth stimulators.

These class III medical devices use a low-level pulsed electromagnetic field designed to activate and augment the body’s natural healing process.

The CervicalStim and SpinalStim systems available in the USA will be accompanied by a new application for mobile devices called Stim onTrack. Designed for use with smartphones and other mobile devices, Stim onTrack provides tools designed to help patients follow their prescription, including daily treatment reminders and a device usage calendar. The free mobile app also includes a feature that enables physicians to receive real-time data on how their patients are adhering to their prescribed treatment protocol.

The next-generation bone growth stimulators include patient enhancements aimed at improving fit, comfort and ease of use.

“Patient recovery is often dependent on how well they follow the prescription for the device,” says James Ryaby, chief scientific officer at Orthofix. “Equipping patients with a mobile app to help them adhere to their prescription is an excellent addition to this system while simultaneously enhancing post-surgical care by giving physicians additional data to help personalise follow-up protocols.”

The North American Spine Society (NASS) recently issued first-of-its-kind coverage recommendations for electrical bone growth stimulators. According to a press release from Orthofix, these policy recommendations support the use of pulsed electromagnetic field stimulation devices as an adjunct to spinal fusion surgery.