Orthofix Medical
(NASDAQ: OFIX)
today announced new data investigating pulsed electromagnetic field (PEMF) stimulation with lumbar fusion surgery.
Lewisville, Texas-based Orthofix has evaluated PEMF stimulation as an adjunct to lumbar fusion surgery in patients at risk for pseudoarthrosis. Patients treated with the SpinalStim Bone Growth Device had a high rate of successful fusion. They also showed significant improvements in pain, function, and quality of life despite having risk factors for pseudarthrosis.
SpinalStim, an FDA-approved bone growth stimulation therapy, provides an adjunctive treatment to lumbar fusion surgery. It also serves as a non-surgical treatment for pseudoarthrosis. This device utilizes PEMF technology that provides a 360-degree treatment range around the fixation site.
Orthofix says its system has an overall success rate of 92% in treating spinal fusion patients.
Researchers have provided data evaluating the SpinalStim system. International Journal of Spine Surgery. Lead author Dr. Mark Weinstein said the data support the use of PEMF stimulation to improve outcomes after lumbar fusion surgery.
Researchers conducted the study at 10 centers in the United States and analyzed a total of 142 patients. In this study, participants were assigned to use his SpinalStim device at home for six months after surgery. Union was determined by radiographic images at 12 months of age.
Fusion success rates for patients with 1, 2, or 3 or more risk factors were 88.5%, 87.5%, and 82.3%, respectively. Patient-reported outcomes also showed significant improvement compared to baseline. It takes into account disability, function, pain, quality of life, and overall health.
“The SpinalStim Bone Growth Therapy Device provides a non-invasive, cost-effective means to enhance spinal fusion procedures, allowing patients to continue their healing at home,” said Kevin Kenny, President of Orthofix Global Spine. says Mr. “This new data is important as it adds to the body of evidence supporting the use of PEMF in high-risk patients facing challenges in bone union healing.”
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