It is important to read the information in the supplemental manual in its entirety before conducting or recommending an MRI examination on a patient with a WaveWriter Alpha or WaveWriter Alpha Prime SCS System. The 1.5T MRI system can be configured to use the Full Body, Head, and Extremity transmit/receive RF quadrature coils, and receive only coils of any type. An MRI examination can be conducted safely only when using a 1.5 Tesla horizontal closed bore whole body MRI system for the MRI scan and following all instructions in the supplemental manual “ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems”. Magnetic Resonance Imaging (MRI) - The WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems are “MR Conditional”. System integrity could be compromised and harm or injury to the patient could occur if the medical devices are subjected to unauthorized modification. SAFETY INFORMATION WARNING: Unauthorized modification to the medical devices is prohibited. have failed trial stimulation by failing to receive effective pain relief Refer to the Instructions for Use provided with the SCS System or for potential adverse effects, warnings, and precautions prior to using this product.ĬONTRAINDICATIONS: Patients contraindicated for permanent Spinal Cord Stimulation (SCS) therapy are those who: Only paresthesia-based stimulation mode has been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 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. 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. † Superion™ Indirect Decompression System Full stimulation parameter ranges and options for both paresthesia based and sub-perception therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS. Sub-perception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months. Information provided for educational purposes only. Results from different clinical investigations are not directly comparable. Results from clinical studies are not predictive of results in other studies. Surround Inhibition Mediates Pain Relief by Low Amplitude Spinal Cord Stimulation: Modeling and Measurement. Twenty-Sixth Annual Meeting of the North American Neuromodulation Society, January 12-15, 2023.įAST MOA computational modeling by Gilbert JE, Titus N, Zhang T, Esteller R, Grill WM. Clinical Outcomes of a Novel, Fast-Acting Sub-Perception SCS Therapy Engaging Surround Inhibition (FAST Prospective Study). A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain. Metzger CS, Hammond MB, Paz-Solis JF, et al. Twenty-Sixth Annual Meeting of the North American Neuromodulation Society, January 12-15, 2023.Ģ. Clinical Outcomes Using A New Fast-Acting Sub-Perception Therapy For Chronic Pain: A Multicenter European Observational Real-World Study. *MRI Conditional under specified conditionsġ.
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