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Warnings. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). The Precision Montage™ MRI, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems with ImageReady™ MRI Full Body Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Full Body Guidelines for Precision Montage™ MRI or WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems. 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.īoston Scientific’s ImageReady™ MRI Full Body Technology makes safe MRI scans possible. 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.īoston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Associated conditions and etiologies may be: 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.Ĭontraindications. 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. Information provided for educational purposes only. Results from different clinical investigations are not directly comparable. Consult with your physician to determine if you are a candidate for this procedure and what you may gain from the therapy. Patients can experience different levels of pain management and different changes in their activities and use of medications. The patient quotes in this material describe real personal experiences. A spinal cord stimulation service review from a single centre using a single manufacturer over a 7.5 year follow-up period. Neuromodulation: Technology at the Neural Interface. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. 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. January 2020 (N=89) 5. Kapural, Cong Yu, et al. Outcomes of a Prospective Randomized Controlled Trial Utilizing a Spinal Cord System Capable of Multiple Neurostimulation Modalities (COMBO). Gilbert et al., Computational modeling predicts dorsal columns are involved in fast-acting sub-perception spinal cord stimulation (SCS). (N=41) 3. FAST MOA computational modeling by Dr. Thomson, Yu Pei, Roshini Jain, Michael Moffitt, Luca Annecchino & Que Doan (2021) A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain, Expert Review of Medical Devices, DOI: 10.1080/17434440.2021.1890580. Presentation at North American Neuromodulation Society (NANS), Las Vegas, NV, January 11-14, 2018. WHISPER: A Multicenter, Prospective Randomized Controlled Trial Evaluating Subperception SCS at ≤ 1.2 kHz. †As measured by the Oswestry Disability Index at 3 months post implant. **MRI conditional when all conditions of use are met. *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.
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