Medtronic (NYSE:MDT) today released three-month results from a post-market clinical study of spinal cord stimulation provided through its EvolveSM workflow, touting effective pain relief and improved function in patients with chronic intractable back and leg pain.
Data from the trial was presented at the American Society of Interventional Pain Physicians’ annual meeting, the Fridley, Minn.-based company said.
The Evolve workflow is intended to help physicians balance high-dose and low-dose therapy using spinal cord stimulation systems, Medtronic said.
“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. 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,” pain therapies division prez Dr. Marshall Stanton said in a press release.
Medtronic said that a total of 103 individuals were implanted with one of its SCS systems, and that 98 patients completed the primary endpoint at three months.
Results from the prospective, single-arm, multi-center Vectors study indicated that 69% of patients had at least a 50% improvement in overall pain. A total of 70% of patients in the trial reported achieving a personal activity goal, and 81% reported satisfaction with their therapy.
Data also indicated that 65% of patients improved at least one disability category in the Oswestry Disability Index, the company said.
“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. 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,” primary trial investigator Dr. John Hatheway of Washington’s Northwest Pain Care of Spokane said in a prepared statement.
Medtronic said that it plans to follow patients in the trial out to six and 12 months follow-ups.
Earlier this month, Medtronic said that it won pre-market approval from the FDA for the CareLink SmartSync device manager for use with its cardiac rhythm management devices.