Orthofix’s New Bone Growth Stimulators Awarded FDA and CE Mark Approvals

Orthofix International N.V., a diversified, global medical device company, today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals for its next-generation CervicalStim and SpinalStim bone growth stimulators. These Class III medical devices use a low-level pulsed electromagnetic field (PEMF) designed to activate and augment the body’s natural healing process, providing patients with a safe, noninvasive treatment option for promoting post-operative spinal fusion.
 
The CervicalStim and SpinalStim systems available in the U.S. 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 to help patients follow their prescription, including daily treatment reminders and a device usage calendar. The mobile app also includes a first-to-market feature that enables physicians to receive real-time data on how their patients are adhering to their prescribed treatment protocol. Stim onTrack is free and available through the iTunes App Store. In addition to the app, the next-generation bone growth stimulators include patient enhancements aimed at improving fit, comfort and ease of use.
 
“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,” said Brad Niemann, President of the Orthofix BioStim strategic business unit. “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.”
 
“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). With a 92 percent clinical success rate when used adjunctively to spinal fusion surgery, 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. The CervicalStim device has an over-all clinical success rate of 84 percent 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. Together, these devices are the number one prescribed bone growth stimulators for spinal fusion.
 
Recently the North American Spine Society (NASS) issued first-of-its-kind coverage recommendations for electrical bone growth stimulators. These evidence-based coverage policy recommendations support the use of PEMF stimulation devices as an adjunct to spinal fusion surgery.
 
A leader in the bone growth stimulation market, Orthofix is dedicated to expanding indications for the use of PEMF devices. The Company is currently conducting two investigational device exemption (IDE) clinical trials to collect safety and effectiveness data of the CervicalStim system for treating odontoid fractures and the Physio-Stim system for osteoarthritis of the knee.