Medtronic has launched a postmarket trial of Evolve, which it recommends for use with its Intellis implantable neurostimulator. Evolve received FDA approval and the CE Mark last year.Medtronic plc
Medtronic seeks to prove high-dose spinal stimulation just as good as low-dose
About 9,000 patients with chronic lower back and leg pain have had a personal trial of Medtronic’s Evolve workflow to help their physicians decide how much high- and/or low-spinal cord stimulation they need to manage pain. Now the company has launched an official postmarket trial of Evolve, which it recommends for use with its Intellis implantable neurostimulator. Evolve received FDA approval and the CE Mark last year.
Medtronic hopes that the Vectors study will produce step-by-step instructions for physicians on how to best use Intellis’ high- and low-dose stimulation to meet each patient’s needs, according to Matt Thomas, general manager of the company’s stimulation and early interventions business. Low-dose stimulation used to be the only option for spinal cord stimulation, and some patients couldn’t tolerate the sensations it produced. Despite its name, high-dose stimulation does not yield such strong feelings or immediate pain relief, Thomas said.
“It gives them versatility,” he said of Intellis. “It doesn’t lock them into one versus the other.”
The trial will begin with high-dose stimulation, and depending on the patient’s response, the physician can make recommendations on how to change the dosage. The patient controls the amount of stimulation received.
“If the patient isn’t feeling the pain relief, you can adjust the high dose or you can do low-dose stimulation,” Thomas said. “Whatever works best for the patient, the patient gets. That’s the essence of Evolve.”
Intellis is among a growing number of spinal cord stimulation implants that medtech companies are producing and touting as alternatives to opioids, which are highly addictive and have led to thousands of overdose deaths nationwide.
Opioids work on the nervous system, dulling specific receptors in the brain to reduce the intensity of pain. In the late 1990s, pharmaceutical companies assured the medical community that patients would not become addicted to prescription opioid pain relievers, opening the floodgates for widespread use—and the eventual misuse—of these incredibly potent drugs.
The first patient in the Evolve trial was enrolled by The Center for Interventional Pain & Spine in Wilmington, Delaware. Medtronic hopes to enroll 175 patients at up to 25 sites nationwide and follow them for one-year post-implant. The company plans to report results of the trial at the North American Neuromodulation Society annual meeting in 2019. At the group’s 2018 meeting, which begins Thursday, Medtronic plans to introduce Snapshot 2.0, an update of a software program that Intellis uses to track patient activity, body positions, and therapy usage.