Medtronic launches post-market SCS programming study

Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its Evolve SM workflow spinal cord stimulation optimization program, having enrolled the first patient in the study.

The first patient in the trial was enrolled at Wilmington, Del.’s Center for Interventional Pain & Spine, the company said.

“Our goal is to improve or restore function. Even with all of today’s technological advances, chronic pain can be challenging to manage; this is further complicated by the opioid crisis. Standard treatment guidance has the potential to help optimize pain relief, and the Vectors Post Market study will provide valuable data about the efficacy of high dose stimulation using standardized programming through the Evolve workflow,” Dr. Michael Fishman of the Center for Interventional Pain & Spine said in a prepared statement.

The Vectors post market clinical study will explore the use of Evolve workflow optimization programming for Fridley, Minn.-based SCS units, including Medtronic’s Intellis SCS platform. The program is designed to standardize guidance to balance low-dose and high-dose therapy settings.

“The Vectors study will generate meaningful data about the use of the Evolve workflow and will help further physicians’ understanding of how to use this simple, versatile approach to enable effective, long-term pain relief with SCS. Knowing how to best use non-opioid treatment options – like the Intellis SCS platform – is more important than ever, and this data may help us expand our ability to help people struggling with chronic intractable pain,” primary investigator Dr. John Hathaway of Spokane, Wash.’s Northwest Pain Care of Spokane said in prepared remarks.

The prospective, multi-center, 12-month study is slated to enroll 175 patients with chronic intractable pain of the lower back and legs at up to 25 US sites looking to explore long-term efficacy and impact on quality of life to provide evidence for the Evolve workflow programming.

“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,” Medtronic pain therapies division prez Dr. Marshall Stanton said in a press release.

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