USA – Saluda Medical, an Australian medical equipment manufacturer, has received FDA approval for its Evoke Spinal Cord Stimulation (SCS) System.

The SCS System is indicated for the treatment of chronic intractable pain, such as unilateral or bilateral pain associated with failed back surgery syndrome, low back pain, and leg pain.

Evoke is billed as the first and only SCS system capable of reading, recording, and responding to evoked compound action potentials (ECAPs) in real time to deliver optimized therapy.

In addition, the system captures and records millions of data points per day in order to provide clinical teams with superior neurophysiological insights.

Unlike other SCS devices on the market, Evoke is designed to maintain optimal pain inhibition by adjusting therapy more than 100 times per second, according to the company.

Saluda Medical president and CEO Jim Schuermann said: “FDA approval for the Evoke System is a significant milestone for Saluda – one resulting from over a decade of advanced research and development.

“Evoke’s innovations are born from John Parker’s vision and pioneering research, and Saluda’s strong and lasting partnerships with the clinical community and mutual dedication to patients.”

The FDA approval is the first for a SCS system and is based on the EVOKE Study, a double-blind randomized controlled trial (RCT).

The study was conducted at 13 sites across the United States, with patients randomly assigned to either ECAP-controlled, closed-loop SCS or open-loop SCS in a 1:1 ratio.

In the trial, the Evoke System served as the investigational and control device for both ECAP-controlled closed-loop SCS and open-loop SCS.

In the RCT, approximately 90% of subjects implanted with the Evoke system demonstrated superior pain relief when compared to open-loop SCS, which was the primary endpoint.

EVOKE Study lead author and medical monitor Nagy Mekhail said: “The groundbreaking technology behind the Evoke System’s ability to intelligently measure spinal cord activation has had many of us excited for a long time.

“More exciting than the technology, though, is the unparalleled quality of the evidence backing this system which demonstrates pain relief coupled with clinically significant improvements in physical and emotional functioning, sleep quality, and health-related quality of life.

“This evidence gives me confidence that Evoke is well-suited to address the unmet need of providing long-term, durable pain relief with this therapy.”

Saluda Medical intends to release the Evoke System in limited quantities for clinical trials in the second half of 2022, with plans to commercialize it in 2023.

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