Australian medical equipment maker Saluda Medical has received the US Food and Drug Administration (FDA) approval for its Evoke Spinal Cord Stimulation (SCS) System.
The SCS System is indicated to treat chronic intractable pain, including unilateral or bilateral pain related to failed back surgery syndrome, low back pain, and leg pain.
Evoke is claimed to be the first and only SCS system capable of instantaneously reading, recording, and responding to evoked compound action potentials (ECAPs) to deliver optimised therapy.
Also, the system captures and records millions of data points per day to provide superior neurophysiological insights to clinical teams.
Unlike other available SCS devices, Evoke has been designed to maintain optimal pain inhibition by adjusting therapy more than 100 times per second, said 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.
“I’d like to personally thank our employees and their families, our clinical investigators and, most importantly, the patients for the unwavering support throughout the process.”
The FDA approval marks the first Premarket Approval (PMA) for an SCS system and is based on a double-blind randomized controlled trial (RCT), dubbed EVOKE Study.
The study was conducted at 13 sites throughout the US, in which patients were randomized in 1:1 ration to receive ECAP-controlled, closed-loop SCS or open-loop SCS.
Evoke System served as the investigational and control device for both ECAP-controlled closed-loop SCS and open-loop SCS in the trial.
In the RCT, around 90% of subjects implanted with Evoke system showed superior pain relief compared to open-loop SCS, which is 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 implement a limited release of the Evoke System in the second half of 2022, for clinical trial use, with plans for commercialisation in 2023.
