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Orthofix announces FDA, CE mark approvals of bone growth stimulators
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Orthofix International NV announced it has received FDA and CE mark approvals for its next-generation bone growth stimulators, the CervicalStim and SpinalStim, according to a company press release.
Both are class III devices that reportedly use a low-level pulsed electromagnetic field to activate and supplement the natural healing process of the body. According to the release, the devices provide a safe, noninvasive treatment option that promotes postoperative spinal fusion.
The SpinalStim reportedly is the only FDA-approved bone growth therapy device to be used as both a lumbar spinal fusion adjunct and a nonoperative treatment option for spinal pseudarthrosis. According to the release, the CervicalStim is the only FDA-approved bone growth therapy device to be used as a noninvasive, adjunctive treatment alternative for cervical fusion in high-risk patients.
The Stim onTrack mobile device application will also be available with the CervicalStim and SpinalStim systems in the United States. The application helps patients follow their prescriptions and allows physicians to receive real-time data on patient adherence to prescribed treatment. The application is free and available through the iTunes App Store.
“With the launch of these new devices, our goal is to redefine the recovery experience of patients using bone growth stimulation devices postoperatively for lumbar and cervical fusion surgical procedures,” Brad Niemann, president of the Orthofix BioStim strategic business unit, said in the release. “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.”
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