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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 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
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
Pulsed Electromagnetic Field noninvasive spinal fusion therapy enhances bone growth and demonstrates statistical significance improves interbody fusion healing.
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
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
84% overall success rate in treating patients with difficult fusions1,2
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.
Pulsed Electromagnetic Field noninvasive spinal fusion therapy enhances bone growth and demonstrates statistical significance improves interbody fusion healing.
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
Connecting Patients and Physicians During the Healing Process
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
‡Superion™ Indirect Decompression System
**Study completers
*Paresthesia-free stimulation has been shown to be safe and effective in patients who have been treated successfully with paresthesia-inducing stimulation for at least 6 months.
†As measured by the Oswestry Disability Index at 3 months post implant.
- Thomson SJ, Kruglov D, Duarte RV. A spinal cord stimulation service review from a single centre using a single manufacturer over a 7.5 year follow-up period. Neuromodulation. 2017;20(6):589-599. N=321
- Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis. Clin Interv Aging. 2017;12:1409-1417. N=88
- North, James, MD. WHISPER: A Multicenter, Prospective Randomized Controlled Trial Evaluating Subperception SCS at ≤ 1.2 kHz. Presentation at North American Neuromodulation Society (NANS), Las Vegas, NV, January 11-14, 2018. (N=70)
- Wallace M. et al. Outcomes of a Prospective Randomized Controlled Trial Utilizing a Spinal Cord System Capable of Multiple Neurostimulation Modalities (COMBO). NANS Annual Meeting. January 2020 (N=89)
- Kapural, Cong Yu, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology 2015; 123:851 -860
- Deer, Timothy, et al. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation: Technology at the Neural Interface. 21. 10.1111/ner.12698
Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.
Indications for Use. The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain, Diabetic Peripheral Neuropathy of the lower extremities, radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.
Contraindications. The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant.
Boston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Patients implanted with the Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems with ImageReady™ MRI Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Head Only Guidelines for Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems.
Boston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Patients implanted with the Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems with ImageReady™ MRI Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Head Only Guidelines for Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems.
Warnings. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For therapy that does not generate paresthesia (i.e. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Indications for Use: The Superion™ Indirect Decompression System (IDS) is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion™ Interspinous Spacer is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5. Contraindications, warnings, precautions, side effects. The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of the device or cause the device to be unstable in situ (i.e., degenerative spondylolisthesis greater than grade 1), Cauda equina syndrome, or prior decompression or fusion at the index level, scoliosis or spinous process fractures, osteoporosis, infection, allergy or reaction to any metal or implant or a high Body Mass Index. Avoid strenuous activity for 6 weeks after surgery, contact your physician if there is fluid leaking from your incision, if you have pain, swelling or numbness in your legs or buttocks or if you fall. Refer to the Instructions for Use provided on www.vertiflex.com for additional Indications for Use, contraindications information and potential adverse effects, warnings, and precautions prior to using this product. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Indications for Use: The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. The Boston Scientific LCED and Stereotactic TCD Electrodes are indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System.
Warnings: The Boston Scientific RF devices may cause interference with active devices such as neurostimulators, cardiac pacemakers, and defibrillators. Interference may affect the action of these active devices or may damage them. For appropriate guidance, consult the instructions for use for these active devices. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
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