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. 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 risks, 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. US 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. 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. Gilbert et al., Computational modeling predicts dorsal columns are involved in fast-acting sub-perception spinal cord stimulation (SCS). Veizi et al, LUMINA Study, Pain Medicine 2015Ĩ. North et al., WHISPER RCT, Neuromodulation 2019ħ. Thomson et al, PROCO RCT, Neuromodulation 2018ĥ. ![]() ![]() Metzger et al., WaveWriter Outcomes, NANS 2022Ĥ. Metzger et al., WaveWriter Outcomes, Expert Review of Med Devices, 2020ģ.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |