Medtronic plc reported 12-month data from a large, multicenter, randomized controlled clinical trial affirming the superiority of differential target multiplexed spinal cord stimulation (DTM SCS) in relieving chronic back pain, vs. traditional SCS therapy, using its Intellis platform. The positive results followed up on data released in January.

Results from the trial showed 84% of patients with chronic back pain who received DTM SCS therapy experienced at least 50% pain relief at 12 months, compared with 51% of patients getting conventional SCS. Moreover, 69% of DTM SCS patients reported profound back pain relief, defined as 80% or greater reduction on the Visual Analog Scale (VAS), vs. 35.1% of those in the SCS group.

The VAS measures pain on a scale of 1 to 10, with 50% pain relief considered the standard for therapy success.

In the study, patients receiving DTM SCS and conventional SCS reported an average reduction in VAS score for back pain of 75% and 50%, respectively. For patients treated with DTM SCS, average VAS scores at 12 months were 1.74 for back pain and 1.45 for leg pain.

Novel approach

Developed by Stimgenics LLC, DTM SCS is a novel spinal cord simulation waveform that modulates both neurons and glial cells, nonneuronal cells in the central and peripheral nervous system that do not produce electrical impulses. Glial cells have been found to outnumber neurons in the spinal cord by 12 to 1.

Earlier this year, Medtronic acquired the Bloomington, Ill.-based spinal cord stimulation startup for an undisclosed sum.

“DTM SCS is based on a novel understanding of how neurons and glial cells contribute to chronic pain,” said Charlie Covert, vice president and general manager of Medtronic’s Pain Therapies business, part of the Restorative Therapies Group. “The 12-month data reported demonstrate the value of Medtronic’s continued focus on pursuing science-based approaches to improving human health and underscore our ability to integrate existing technologies with novel therapies like DTM SCS to improve the outcomes of people suffering from chronic pain.”

The results suggest that DTM SCS can provide more patients with profound and long-term pain relief.

The study previously met its primary outcome of DTM SCS noninferiority vs. conventional SCS at three months, as well as a prespecified secondary analysis showing superiority of DTM SCS. The new data “underscore the durability compared with conventional SCS at 12 months,” Covert told BioWorld.

DTM SCS is currently available on the Intellis SCS platform. Designed to overcome limitations of other SCS systems, such as battery performance, Intellis also features Surescan MRI technology, which allows users to get MRIs with an implant in place, and Adaptivestim technologies, which automatically adjusts stimulation based on patients’ needs and preferences.

During a Tuesday webinar to release the data, Krishnan Chakravarthy, a pain management specialist at the University of California San Diego Center for Pain Medicine, highlighted key takeaways from the study, including the therapy’s “disease-centric innovation, systemic development and looking at the cellular framework as well as the translation to clinical outcomes to really get at the bigger question about where the SCS space is going. “We are at a critical junction in our field, and truly what we define as a paradigm shift.”

Further indications being explored

Dublin-based Medtronic currently is conducting three randomized controlled trials to explore the effectiveness of DTM SCS in three new indications: failed back surgery syndrome, upper limb and neck pain and surgical naїve upper limb and back pain.

“Enrollments in those trials are happening now,” Covert said, adding a study for painful diabetic neuropathy is slated to begin next year.

As Cowen’s Joshua Jennings noted, Medtronic has highlighted SCS as a key growth area within its neuromodulation business.

“MDT projects that the current market opportunity, which is centered on U.S. SCS use for failed back surgery syndrome, can double to approximately $5.5 as technology-driven outcomes improve and new indications become treatable with advanced stimulation. Part of the company’s strategy involves competing effectively in the current market with leading technology and objective evidence, such as the latest DTM data.”

In a Tuesday note, Wells Fargo senior analyst Larry Biegelsen called the DTM SCS results “highly competitive with other novel waveforms” such as Nevro Corp.’s HF10 and Saluda Medical Pty. Ltd.’s Evoke at 12 months, but noted Medtronic’s data is based on a modified intention to treat analysis, making a precise apples-to-apples comparison difficult.

Nonetheless, “our checks indicate that DTM SCS is doing well in the market and we believe the 12 month data will benefit adoption of the therapy because physicians want to see durability of effect,” he wrote.