Dr. Chris Karas doesn’t use the expression lightly.
He performs approximately 200 spinal cord stimulation implants every year at OhioHealth in Columbus, Ohio and considers the Intellis™ spinal cord stimulator a “game-changing” device. “Intellis™ is significantly different,” he said.
One of the key reasons is data. Intellis™ contains embedded technology that records a patient’s position and the amount of time that patient is active. It then utilizes proprietary reporting called Snapshot™ to display the objective data. Doctors can compare what the patients tell them about their pain levels with actual, measurable data about patient activity to see how well the device is working and whether to make therapy adjustments.
“Until Intellis™, we didn’t have access to that kind of quantitative data, even in the hospital,” Dr. Karas said. “This is really going to help us, and the patients, as time goes on. It already has.”
Medtronic designed Intellis™ with “value in healthcare” in mind.
Snapshot™ captures changes in activity level, so physicians can work with patients, set goals, and use actionable data to track how patients are progressing. It provides documented evidence showing the value of these therapies.Dr. Marshall Stanton, SVP and President, Medtronic Pain Therapies
“More and more physicians — as well as hospital administrators and insurers — want to see documentation that people are benefiting from these therapies,” said Dr. Marshall Stanton, senior vice president and president of the Medtronic Pain Therapies business. “Snapshot™ captures changes in activity level, so physicians can work with patients, set goals, and use actionable data to track how patients are progressing. It provides documented evidence showing the value of these therapies.”
Intellis™ is significantly smaller than previous spinal cord stimulators and includes technology that allows the batteries to recharge much faster (testing showed a battery held 95 percent of its capacity at 9 years). Additionally, it contains sensors, which detect a person’s position. The device can modify the amount of stimulation patients receive, depending on the pain they’re experiencing in different positions.
“Spinal cord stimulation really is a very individualized form of treatment,” said Dr. Karas. “It can be specified to the location of their pain and the type of their pain.”
Sixty-year-old Navy veteran Edwin “Skip” Parks appreciates all those capabilities. A series of back operations left him in often unbearable pain. “My pain has gone from a 10-plus to a 6, which for me, is huge. I can live with a 6. It’s given me the ability to be me again. I can function on a daily basis,” he said.
“That outcome — returning patients to more normal lives — is the goal,” says Dr. Karas.
...with spinal cord stimulation, we’re seeing amazing outcomes. We’re seeing them quickly. And we’re seeing improvements in patients’ lives, not just managing their decline. That is very rewarding.Dr. Chris Karas, OhioHealth
“In neurosurgery, we see a lot of things that are untreatable. But with spinal cord stimulation, we’re seeing amazing outcomes. We’re seeing them quickly. And we’re seeing improvements in patients’ lives, not just managing their decline. That is very rewarding.”
Brief Summary: Product manuals must be reviewed prior to use for detailed disclosure.
Implantable neurostimulation systems - A Medtronic 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:
Diathermy - 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.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
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