![]() The “ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems” manual appears on the Boston Scientific websites ( and MRI examinations performed on patients with the WaveWriter Alpha or WaveWriter Alpha Prime SCS System using open-sided MRI systems, or other types of MRI systems operating at other static magnetic field strengths (higher or lower), have not been assessed and, as such, should not be performed. 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: The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. Contraindications, warnings, precautions, side effects. ![]() 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. 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. ![]()
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