![]() MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain. ![]() ‡ ImageReady(TM) MRI Full Body Guidelines for WaveWriter Alpha(TM) and WaveWriter Alpha(TM) Prime Spinal Cord Stimulator Systems. *MRI Conditional under specified conditions The WaveWriter Alpha™ SCS System provides safe access to full-body MRI scans when used with specific components and the patient is exposed to the MRI environment under the defined conditions in the ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator System. Federal law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use provided with the SCS System or for potential adverse effects, warnings, and precautions prior to using this product. Only paresthesia-based stimulation mode has been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 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. 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, Diabetic Peripheral Neuropathy of the lower extremities, intractable low back pain and leg pain.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |