The Vectors Post market clinical study will evaluate SCS long-term efficacy and impact on quality of life.
The trial will follow patients with chronic intractable pain who are undergoing SCS treatment managed with the Evolve workflow that standardizes guidance to balance high-dose (HD) and low-dose (LD) therapy settings to allow physicians enhance treatment.
Evolve works on Medtronic SCS systems such as Intellis, which is claimed to be the world's smallest implantable SCS neurostimulator that secured US FDA and CE mark approvals.
In the study, Medtronic has recruited the first patient at The Center for Interventional Pain & Spine in Wilmington, Delaware.
The study is a prospective, multi-center and post-marketing trial, which will recruit around 175 patients with chronic intractable pain of the low back and legs at up to 25 sites in the US.
The company has designed the study to offer evidence for the Evolve workflow by assessing the effectiveness and potential patient benefits of having access to both HD and LD stimulation modalities.
With the support of Medtronic's Overdrive battery technology, the Intellis platform can be fully recharged in around one hour.
Physicians can also use new tools such as Snapshot to track activity, body positions and therapy usage.
Medtronic's pain therapies division president and senior vice president Dr Marshall Stanton said: "Medtronic is committed to advancing the treatment of people with intractable chronic pain. To maximize our impact, our goal is to expand the clinical understanding of optimal approaches to SCS treatment.
"Building on our 40-year legacy, the Vectors study will provide important evidence about how to best leverage both high dose and low dose stimulation with the Evolve workflow, which was designed to simplify patient management and standardize therapy for the best possible outcome. It's not just about pain relief, but about return to function."
Image: Medtronic operational headquarters. Photo: courtesy of Medtronic.
