PATIENT SELECTION SPINAL CORD STIMULATION

CANDIDATES FOR SPINAL CORD STIMULATION

The overall goal for patient selection for spinal cord stimulation is to choose those patients most likely to experience therapeutic success while reducing the likelihood of risks, complications, and adverse events. A careful assessment by a multidisciplinary team, and discussion of the patient's expectations and goals, will help identify appropriate candidates for spinal cord stimulation.

Spinal Cord Stimulation is an aid in the management of chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following conditions:

  • Failed Back Syndrome (FBS) or low back syndrome or failed back
  • Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk
  • Postlaminectomy pain
  • Multiple back operations
  • Unsuccessful disk surgery
  • Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions
  • Peripheral causalgia
  • Epidural fibrosis
  • Arachnoiditis or lumbar adhesive arachnoiditis
  • Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia

The safety and effectiveness of this therapy has not been established for pregnancy, unborn fetus or delivery.

If a patient does not respond well to neurostimulation, he or she may be a candidate for Targeted Drug Delivery.


Patient Selection FOR SPINAL CORD STIMULATION

Spinal cord stimulation may benefit certain patients who meet the following criteria:

  • Chronic, intractable pain of the trunk and/or limbs
  • No contraindications to therapy or surgery
  • Patient can properly operate system
  • Patient understands therapy risks
  • Satisfactory results from test stimulation
  • Patient is not pregnant
  • Clearance and completion of psychological evaluation
  • 18 years of age or older
  • They are appropriate candidates for surgery
  • Their symptoms are of physiological origin

SCREENING TRIAL

A screening trial allows patients to assess their response to spinal cord stimulation prior to device implantation. Patients who experience adequate pain relief from the screening trial may be candidates for an implanted neurostimulation system.

The screening trial:

  • Offers an opportunity to gauge patient response prior to device implantation
  • May last for up to 10 days

The EvolveSM Workflow offers you standardized guidance for trialing of spinal cord stimulation, balancing simplicity with the versatility of High Dose and Low Dose stimulation.

A workflow is guidance only. Physicians should use their medical judgment and product labeling to optimize therapy for individual patients, which may require discontinuation or modification of a workflow.