A new clinical study demonstrates effective relief in patients suffering intractable back and leg pain, when treated with spinal cord stimulation (SCS) utilizing the EvolveSM workflow.
Neurostimulation has been proven to provide effective long-term pain relief and improve quality of life, and may be a non-drug treatment option for patients who do not get adequate pain relief from medication alone. Medtronic neurostimulation therapy for chronic intractable pain uses 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.
Now the company has announced primary endpoint (3-month) results of the Vectors Post Market Clinical Study into its EvolveSM workflow. Medtronic offers the Evolve workflow to help physicians balance high-dose (HD) and low-dose (LD) therapy settings on Medtronic SCS systems, including the Intellis™ platform.
The prospective, single-arm, multicenter Vectors study was designed to provide evidence for the Evolve workflow by assessing the effectiveness and potential patient benefits of SCS while having access to both HD and LD stimulation modalities. The study was conducted with Intellis, the world’s smallest fully implantable spinal cord stimulator, with Medtronic’s proprietary AdaptiveStim™ technology. The study will continue to follow patients through 6- and 12-month follow-up.
SCS has traditionally used LD stimulation (40 Hz); however, HD stimulation (1000 Hz), the starting point for the Evolve Workflow, is becoming a more common starting frequency. At three months, 96 percent of patients remained on HD therapy alone.
Results were presented at the American Society of Interventional Pain Physicians (ASIPP) annual meeting and found that patients experienced a statistically significant and clinically meaningful3 improvement with 69 percent of patients experiencing ≥ 50 percent improvement in overall pain and 70 percent achieving a personal activity goal at three months.
Ninety percent of study subjects had a successful screening trial. 103 were then implanted with the device, and 98 patients completed the primary endpoint (3-month) visit. Data from the study demonstrated sustained pain relief, improved quality of life and decreased disability after device implant. 69 percent of patients had at least a 50 percent improvement in overall pain, 70 percent of patients achieved a personal activity goal, 81 percent of patients were satisfied with their therapy and 65 percent improved at least one disability category in the Oswestry Disability Index (ODI).
Importantly, Medtronic points out that a workflow is for guidance only and physicians should use their medical judgment and product labeling to optimize therapy for individual patients. As such treatment may include the need to discontinue or modify said workflow.
“More and more clinicians are seeking long-term, non-opioid treatments for chronic pain, so it’s important to understand how to best optimize SCS treatment with tools like the Evolve workflow,” said John Hatheway, M.D., Northwest Pain Care of Spokane, Washington and primary investigator. “The potential for SCS to provide meaningful long-term improvements in quality of life, activities of daily living, and function is critical. It’s encouraging that results from the Vectors study are showing effective pain relief and improved patient function.”
“Every patient is different, and to truly advance patient care we need clinical evidence that demonstrates significant benefits in pain relief and also looks beyond that to patient quality of life, function and satisfaction,” said Marshall Stanton, M.D., senior vice president and president of Medtronic’s Pain Therapies division, which is part of the Restorative Therapies Group. “Medtronic’s goal is to help clinicians maximize the potential impact of SCS and give their patients the best possible long-term outcomes. We continue to invest in research, like the Vectors study, to build clinical evidence and understand how we can continue to strive for the best therapy options for each individual patient.”
J Hatheway, MD. (2019, May). High Dose (HD) and Low Dose (LD) Spinal Cord Stimulation (SCS) for the effective treatment of Chronic Back and Leg Pain: Pain Responders. Poster presented at the American Society of Interventional Pain Physicians annual meeting, Las Vegas, NV.
M Fishman, MD. (2019, May). High Dose (HD) and Low Dose (LD) Spinal Cord Stimulation (SCS) for the effective treatment of Chronic Back and Leg Pain: Improvements in Function. Poster presented at the American Society of Interventional Pain Physicians annual meeting, Las Vegas, NV.
Source: Medtronic plc