Spinal Fusion Therapy
When undergoing spinal fusion surgery, patients who possess certain risk factors are more likely to experience sub-optimal fusion. Orthofix Bone Growth Therapy devices provide a safe, noninvasive treatment that helps promote healing in spinal fusions that have not healed or have difficulty healing. The devices stimulate the bone’s natural healing process by sending low-level pulses of electromagnetic energy to the fusion site.
About Spinal Fusion Therapy
Orthofix Bone Growth Therapy devices used in spinal applications are designed to enhance bone growth and the success rate of certain spinal fusions by stimulating the body’s own natural healing mechanism post-surgically.
There are many reasons for spinal fusion surgery, typically they include: vertebral fractures, deformity correction, elimination of pain from motion, vertebral instability, degenerative disc disease, spondylolisthesis, spinal stenosis, tumors, and treatment of some disc herniations.
Spinal fusion surgery involves the use of bone graft to fuse vertebral bodies together into a single, solid bone and can be grafted using autograph, allograph, or synthetic bone graft material. Additionally, spinal fusions may utilize hardware such as metal plates, rods, or screws to help secure the vertebrae.
Bone Growth Therapy for spinal applications uses a Pulsed Electromagnetic Field (PEMF) to stimulate osteogenic principles. PEMF spinal fusion therapy has been found to increase the probability of fusion success in compliant patients regardless of bone graft material and/or hardware presence.*7
#1 Prescribed Bone Growth Stimulator18
PEMF technology approved since 1986
Over 1,000,000 prescribed devices
Pulsed Electromagnetic Field noninvasive spinal fusion therapy enhances bone growth and demonstrates statistical significance improves interbody fusion healing.
Why do Physicians Prescribe the SpinalStim Device?
The SpinalStim device has been approved by the FDA to be used after spinal fusion surgery or to be used to treat a failed fusion from previous surgery. For complete prescribing information, please refer to the Instruction Manual.
92% overall success rate in treating patients with difficult fusions6,7
Statistically significant results for patients who smoke or have a multi-level fusion6,7
67% overall success rate for pseudarthrosis salvage users6,8
360 degrees of PEMF treatment signal around fusion site4
Patients who use electrical or electromagnetic stimulation devices are two times as likely to achieve vertebral fusion9
Supported by the North American Spine Society’s coverage recommendations5
Pulsed Electromagnetic Field noninvasive cervical spinal fusion therapy enhances bone growth and increases the probability of fusion success.
Why do Physicians Prescribe the CervicalStim Device?
The Cervical Stim device has been approved by the FDA to be worn after cervical spine fusion surgery in patients at risk for non-fusion. Please refer to the instruction manual for complete prescribing information.
84% overall success rate in treating patients with difficult fusions1,2
91% fusion success rate for patients who displayed three or more risk factors for pseudarthrosis3
Statistically significant results for patients who smoke or have a multi-level fusion1,2
360 degrees of PEMF treatment signal around fusion site4
58% reduction in VAS Neck Pain3
Supported by the North American Spine Society’s coverage recommendations5
Devices Designed With the Patient in Mind
The SpinalStim™ and CervicalStim ™ devices are single pieces that are lightweight, flexible, and portable, allowing freedom of movement during treatment. An LCD and an audible alarm provide important feedback during treatment such as the operational status, treatment time remaining, battery capacity, and when paired with STIM onTrack™ patient mobile-app recovery is designed for success.
Common Surgical Procedures for our Devices
ACDF: An anterior cervical discectomy and fusion surgery is done for symptomatic cervical disc problems, most commonly for a cervical herniated disc. It can also be done to address problems from degenerative disc disease, spinal stenosis and/or osteoarthritis in the cervical spine. For example, during the ACDF surgery, osteophytes (bones spurs) and any extra disc material associated with those conditions may also be removed.
PLIF: Posterior lumbar interbody fusion is a spinal fusion surgical approach to fuse the disc space of the spine through entering from the back of the body. An incision is made at the midline of the back and the left and right erector spinae muscles are stripped of the lamina of the affected vertebrae to allow access to the nerve roots.
ALIF: Anterior lumbar interbody fusion is a type of back surgery used to fuse the disc space of the spine through entering the front of the body through the abdomen. In an ALIF, an incision is made on the left side of the abdomen and the abdominal contents and muscles are pulled to the side to allow access to the front of the spine.
TLIF: Transforaminal lumbar interbody fusion is a form of spine fusion surgery in which the lumbar disc space is fused from a posterior approach outside of the facet joint. The surgical procedure involves removing a disc from between two vertebrae and fusing the vertebrae together.
XLIF: Extreme lateral interbody fusion is a minimally invasive surgical procedure that fuses two levels of the spine using an approach from the side of the lower back. The surgery typically involves the removal of the spinal disc and placement of an interbody cage filled with bone graft in the disc space. The treated segments are then secured with fusion instrumentation, such as pedicle screws and rods.
Connecting Patients and Physicians During the Healing Process
Orthofix DIRECT™ and the STIM onTrack™ mobile application use advanced, innovative technology to connect physicians and patients when using bone healing solutions, regardless of where they are located.
Trusted Technology
Easy to Navigate Features
Centralized Support for Patients Treating with a Bone Growth Therapy device
The Technology Behind SpinalStim and CervicalStim
Orthofix Bone Growth Therapy devices create a low-level pulsed electromagnetic field (PEMF), which helps activate the body’s natural healing process.10-12 The PEMF signal is produced from a coil built into a fabric garment that is worn over the fracture or fusion site. The garment can be worn over clothing, casts, or braces. Published pre-clinical research shows that PEMF affects bone healing processes at the molecular, cellular and tissue levels.*13-17 At the cellular level, the PEMF signal activates bone growth signaling pathways, which enhances bone formation by increasing both the population and maturity of the bone building cells.*13,16 At the tissue level this leads to stronger, higher density bone.*15,17
Brief Prescribing Information:
Full prescribing information can be found in product labeling on our patient education website www.BoneGrowthTherapy.com or by calling Patient Services at 1-800-535-4492.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The CervicalStim™ device is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion; there are no known contraindications.
Do not use this device if you have a cardiac pacemaker or defibrillator. Remove the device prior to any imaging procedures. The safety of this device for use on patients who are pregnant or nursing has not been established. Adverse effects may include increased pain, numbness and tingling, headache, migraines and nausea; these effects may or may not be directly related to use of the device.
The SpinalStim™ device is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
Cardiac pacemakers may be adversely affected by exposure to pulsed electromagnetic fields. Use of this device is contraindicated where the individual has an implanted cardiac pacemaker. The safety and effectiveness of this device has not been established for individuals lacking skeletal maturity. The safety of this device for use on patients who are pregnant or nursing has not been established. Rare instances of reversible minor discomfort have been reported.
*STIM onTrack mobile app is available as an accessory for US model devices only.
References:
- 1. PMA P030034. December 2004.
- Foley KT, Mroz TE, Arnold PM, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J. 2008;8(3):436-442
- Data on file 2023
- Data on file. Field mapping analysis conducted by M. Zborowski, Ph.D., Cleveland Clinic
- Spine.org
- PMA P850007/S6. February 1990.
- Mooney V. Pulsed electromagnetic fields: an adjunct to interbody spinal fusion surgery in the high risk patient. Surg Technol Int 1993, 2:405-410
- Simmons JW Jr, Mooney V, Thacker I. Pseudarthrosis after lumbar spine fusion: nonoperative salvage with pulsed electro¬magnetic fields. Am J Orthop. 2004;33(1):27-30
- Ethan Cottrill, MS, Zach Pennington, BS, A. Karim Ahmed, BS, Daniel Lubelski, MD, Matthew L. Goodwin, MD, PhD, Alexander Perdomo-Pantoja, MD, Erick M. Westbroek, MD, Nicholas Theodore, MD, Timothy Witham, MD, and Daniel Sciubba, MD Department of Neurosurgery, The Johns Hopkins School of Medicine, Baltimore, Maryland The effect of electrical stimulation therapies on spinal fusion: a cross-disciplinary systematic review and meta-analysis of the preclinical and clinical data SOURCE: J Neurosurg Spine, October 8, 2019
- Bassett, CA. Fundamental and practical aspects of therapeutic uses of pulsed electromagnetic fields (PEMFs). Crit Rev Biomed Eng. 1989; 17(5):451-529
- Yen-Patton GP, et al. Endothelial cell response to pulsed electromagnetic fields: stimulation of growth rate and angiogenesis in vitro. J Cell Physiol. 1988 Jan; 134(1): 37-46
- Zoltan, JD. Electrical Stimulation of Bone: An Overview. Seminars in Orthopaedics, Vol 1, No 4 (December), 1986: 242-252
- Patterson TE, Sakai Y, Grabiner MD, et al. Exposure of murine cells to pulsed electromagnetic fields rapidly activates the mTOR-signaling pathway. Bioelectromagnetics. 2006;27(7):535-44
- Selvamurugan N, Kwok S, Vasilov A, Jefcoat SC, Partridge NC. Effects of BMP-2 and pulsed electromagnetic field (PEMF) on rat primary osteoblastic cell proliferation and gene expression. J Orthop Res. 2007;25(9):1213-20
- Midura RJ, Ibiwoye MO, Powell, KA, et al. Pulsed electromagnetic field treatments enhance the healing of fibular osteotomies. J Orthop Res. 2005;23:1035-46
- Schnoke M, Midura RJ. Pulsed electromagnetic fields rapidly modulate intracellular signaling events in osteoblastic cells: comparison to parathyroid hormone and insulin. J Orthop Res. 2007;25(7):933-40
- Ibiwoye MO, Powell KA, Grabiner MD. Bone mass is preserved in a critical-sized osteotomy by low energy pulsed electromagnetic fields as quantitated by in vivo micro-computed tomography. J Orthop Res. 2004;22(5):1086-93
- iData Research Inc., U.S. Market for Spinal Implants and VCF (iDATA_USSP19_RPT), iData Research Inc (www.idataresearch.net) 2021