Spinal Cord Stimulation (SCS)

Yes. Recent data as well as historical data^1-3 on Medtronic SCS devices demonstrate the breadth and depth of clinical evidence on Medtronic SCS systems that support the overall performance and safety, and ultimately the benefit-risk acceptability, of SCS therapy for chronic, intractable non-cancer pain of the trunk and/or limbs.

Medtronic stands behind the safety and efficacy of all its therapies, including SCS therapy which has provided an option for patients who have failed more conservative interventions, such as injections, radiofrequency ablations, or surgery. This confidence is based on the wealth of performance and safety evidence on Medtronic SCS devices from multiple clinical data sources, including:

• Peer-reviewed clinical literature
• A range of Medtronic-sponsored or acquired clinical investigations
• A long-standing Medtronic-sponsored registry
• Our standard post-market surveillance activities, such as complaint reporting
• 40-year history with SCS therapy

Patients with chronic pain have limited options for relief, and all treatment options, including SCS, are associated with some level of risk. Risks of SCS include infection, lead movement, pain at the implant site, and loss of therapy effectiveness. Not everyone responds to SCS in the same way, and your experiences may vary. Patients with diabetes may have an increased risk for surgical complications.

SCS therapy offers certain advantages over alternative treatment options. SCS therapy is also reversible as devices can be removed, unlike conventional surgical and ablative therapies. Moreover, in contrast to chronic opioid treatments, SCS therapy is not associated with a risk of addiction or a risk of life-threatening overdose. Therefore, SCS therapy is an important treatment option for patients with chronic pain. 

Yes, Medtronic SCS devices are approved by the U.S. FDA and other health regulators. SCS devices are a proven way to manage chronic pain – helping patients rediscover life and get back to doing the things they love in nearly 100 countries where Medtronic SCS options are approved by health regulatory agencies.

SCS therapy is a treatment option for patients who have attempted other more conservative therapies to treat their chronic pain and have not experienced adequate relief. When these treatments have been exhausted, patients may consider an implantable SCS device as an option. 

Before committing to an implantable SCS system, some patients have the option to undergo a trial to ensure the therapy is right for them before moving ahead to implant. Results from the trial are helpful for a physician to decide whether an implantable SCS system is appropriate for a patient to help manage their pain. 

SCS is the application of mild electrical stimulation of the spinal cord via leads that deliver mild electrical impulses to an area near the spine, interrupting pain signals before they reach the brain for personalized pain relief.

SCS therapy is a treatment option for patient populations that have failed more conservative treatments for chronic pain. SCS therapy for chronic pain is not considered a first line treatment. 

Many individuals with chronic pain suffer for years in search of treatments to relieve their pain. Medtronic brought SCS therapy to patients more than 40 years ago to fill a gap in the treatment continuum and provide a much-needed solution for these patients who have failed more conservative interventions, such as injections, radiofrequency ablations, or surgery.

For decades, SCS therapy has been indicated and used to treat chronic intractable non-cancer pain of the trunk and/or limbs. This includes patients who experience pain indications 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 disc
• Post-laminectomy 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
• Diabetic periperal neuropathy of the lower extremities

A patient undergoes a trial (also known as a screening test) before committing to an implantable system. Results from the screening test are helpful for a doctor to decide whether an implantable SCS system is appropriate for a patient to help manage their pain. If results from the screening test are favorable, a patient may proceed with long-term therapy. 

There may be situations where, following a screening test, a patient and doctor may decide not to move forward with an SCS system to help manage chronic pain. This may be due to inadequate pain relief during the screening test period or if patients dislike or are not able to tolerate the sensation associated with the stimulation from an SCS system. The patient or physician may also decide not to go forward due to the required follow-up care or the patient’s inability or refusal to use and manage the system.