EMA Puget Sound Is on of the First and Only in Western Washington to Offer the Next Generation Medtronic Spinal Cord Stimulator for the Long-Term Management of Chronic Pain.
Positive News for People with Chronic Pain: EMA Puget Sound is one of the first in Western Washington to offer the Intellis™ platform, including the world’s smallest implantable spinal cord stimulator (SCS) for the management of certain types of chronic intractable pain. Chronic pain is a debilitating condition that can negatively impact all aspects of a person’s life – relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated.1 Now, WA residents have access to a new cutting-edge treatment option.
Chronic pain takes an emotional and economic toll on individual sufferers, their families and friends, co-workers, employers and communities. While it is a very personal issue, chronic pain is a significant public health problem. Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain.1
Medtronic neurostimulation therapy for chronic pain uses an SCS system, which is a medical device placed under a patient’s skin to deliver mild electrical impulses through a lead implanted in the epidural space to block pain signals from going to the brain. Neurostimulation has been proven to provide effective long-term pain relief and improve quality of life, in addition to being a treatment option for patients interested in trying a non-drug alternative.2-6
SCS is a non-opioid therapy that is clinically proven and cost-effective for treating chronic pain. Multiple randomized controlled trials have demonstrated that SCS provides more effective pain relief than both re-operation and conventional medical management.2-4,7
Chronic pain is challenging to treat and our goal is to restore patient’s mobility and improve their quality of life with effective long-term pain relief. Given the national crisis involving opioid abuse, it’s more important than ever to offer an effective, long-term solution.
An implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system 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 conditions:
Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted electrodes, resulting in severe injury or death.
Sources of strong electromagnetic interference (e.g., defibrillation, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device (e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device.
The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or delivery. To properly assess test stimulation, patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions provided in product manuals. Patients
should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other activities may cause shocking or jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging.
Adverse events may include: undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, gastrointestinal symptoms (diarrhea, constipation, and leakage of stool), bladder symptoms (urinary retention and frequency and leakage of urine) and surgical risks.