Orthofix International has secured the US Food and Drug Administration (FDA) clearance and CE mark approval for its next-generation CervicalStim and SpinalStim bone growth stimulators.
The Class III medical devices will deploy low-level pulsed electromagnetic field (PEMF) to activate and increase the body's natural healing process, providing patients with noninvasive treatment to promote post-operative spinal fusion.
SpinalStim is claimed to be the only FDA-approved bone growth therapy device device as both a lumbar spinal fusion adjunct and a non-surgical treatment for spinal pseudarthrosis.
CervicalStim device is the bone growth therapy device that has been FDA-approved as a noninvasive and adjunctive treatment option for cervical fusion in high risk patients.
CervicalStim and SpinalStim systems provided in the US feature new mobile application called Stim onTrack.
Developed to be used with smartphones and other mobile devices, Stim onTrack includes tools that will enable patients to follow their prescription, including daily treatment reminders and device usage calendar.
The mobile app also includes new feature that allows physicians to secure real-time data on how their patients are adhering to their prescribed treatment protocol.
Orthofix BioStim strategic business unit president Brad Niemann said: “With the launch of these new devices, our goal is to redefine the recovery experience of patients using bone growth stimulation devices post-operatively for lumbar and cervical fusion surgical procedures.
“We are proud to offer the addition of Stim onTrack to our CervicalStim and SpinalStim devices as we continue to find ways to partner with physicians in achieving improved clinical outcomes.”
Image: Orthofix’s SpinalStim and CervicalStim bone growth stimulators. Photo: courtesy of Business Wire.