Following a multicenter retrospective evaluation, data was collected from 55 patients diagnosed with lumbar degenerative disease, spinal stenosis, and/or spondylolistheses who underwent three- or four-level arthrodesis surgery followed by PEMF treatment with the SpinalStim device
Illustration of the Orthofix SpinalStim Bone Growth Therapy device for patients recovering from lumbar fusion surgery. (Photo: Business Wire)
Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the publication of retrospective data evaluating fusion rates in patients receiving three- and four-level lumbar arthrodesis surgery who were treated adjunctively with the SpinalStim™ bone growth therapy device.
Published in The International Journal of Spine Surgery, the study results show a 92.7-percent fusion rate in patients with and without risk factors such as diabetes, obesity, tobacco use, advanced age and osteoporosis − conditions that have been linked to higher rates of nonunion or bone healing complications.
“We set out to evaluate the success rate of Pulsed Electromagnetic Field Stimulation (PEMF) therapy to demonstrate the efficacy when used as an adjunctive treatment in patients receiving three- and four-level lumbar fusion surgery,” said Dr. Kris Radcliff, Professor of Orthopedic and Neurological Surgery at Thomas Jefferson University. “The fusion rate was very good across all patient types including those who were potentially at high risk of fusion failure. These results reconfirm the benefit PEMF therapy can provide patients when used after multi-level lumbar fusion surgery.”
Following a multicenter retrospective evaluation, data was collected from 55 patients diagnosed with lumbar degenerative disease, spinal stenosis, and/or spondylolistheses who underwent three- or four-level arthrodesis surgery followed by PEMF treatment with the SpinalStim device. At 12-month follow-up, radiographic evaluation of overall fusion rates was 92.7 percent regardless of patient risk factors.
“This data confirms that the efficacy seen in the original Orthofix IDE clinical study of PEMF stimulation with the SpinalStim bone growth therapy system in patients with one- and two-level lumbar procedures is also demonstrated in three- and four-level fusion surgery patients,” said Orthofix President of Global Spine Kevin Kenny. “Importantly, these results include data from patients who were at high clinical risk of fusion failure. It is very rewarding to know that our SpinalStim bone growth therapy system can be a benefit to patients whose recovery from arthrodesis surgery can be challenging.”
About the SpinalStim Bone Growth Therapy Device
The SpinalStim device is the only bone growth stimulator approved by the U.S. Food and Drug Administration as an adjunct for lumbar spinal fusion procedures and as an option for treating failed spinal fusion surgery. The device emits 360 degrees of PEMF treatment around the fusion site, covering up to five vertebral levels. The SpinalStim system is supported by the STIM onTrack™ mobile app that enables patients to take an active role in their recovery through daily treatment reminders, usage calendars and the sharing of treatment data with physicians.
Source: Company Press Release