The FDA has granted Supplemental Approval for a mobile device app for Orthofix International N.V.’s bone graft stimulators that help patients follow their prescription and allows their physicians to see if the patients are following instructions.
FDA Supplemental Approval for Orthofix Mobile App for Stimulators
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On January 9, 2017, the company announced the approval for its CervicalStim and SpinalStim bone graft stimulators.
There’s an App for That
The approval is for a “first-to-market” mobile device app called Stim onTrack. The app provides tools to help patients follow their prescription, including daily treatment reminders and a device usage calendar. The mobile app has a first of its kind feature that enables physicians to receive real-time data on how their patients are adhering to their prescribed treatment protocol.
“Patient recovery is often dependent on how well they follow the prescription for the device, ” said James Ryaby, Ph.D., 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 personalize follow-up protocols.”
These next-generation devices are the latest in a line of bone growth stimulator systems that Orthofix first introduced into the market in 1990 (SpinalStim) and 2004 (CervicalStim).
The company says the SpinalStim device is the only bone growth therapy device approved by the FDA as both a lumbar spinal fusion adjunct and as a non-surgical treatment for spinal pseudarthrosis and has a 92% clinical success rate when used adjunctively to spinal fusion surgery.
The CervicalStim device, according to the company, has an over-all clinical success rate of 84% and is the only bone growth therapy device approved by the FDA as a noninvasive, adjunctive treatment option for cervical fusion in high risk patients. The company also says the devices are the number one prescribed bone growth stimulators for spinal fusion.
The North American Spine Society (NASS) recently issued a first-of-its-kind coverage recommendations for electrical bone growth stimulators. The stimulators are Class III medical devices using a low-level pulsed electromagnetic field (PEMF) designed to activate and augment the body’s natural healing process and provide patients with a noninvasive treatment option for promoting post-operative spinal fusion.
The company also announced CE Mark approval of the app.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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