#Minneapolis #Australia #Saluda Medical #Evoke System #EVA Sensing

Saluda Medical Expands with EVA™ Sensing Technology Approval

Saluda Medical, Inc., a company based in Minneapolis, has made significant strides in the medical device industry with the recent CE certification of its revolutionary EVA™ Sensing Technology. This approval not only marks a significant milestone for the company's expansion into the European market but also recognizes the technology's benefits in Australia. The EVA™ technology is part of Saluda’s innovative approach to treating chronic neurological conditions, leveraging real-time spinal cord data to enhance patient therapy outcomes.

This newly-approved framework builds upon the existing Evoke® System, the pioneering closed-loop spinal cord stimulation (SCS) device that has redefined pain management for many patients. Historically, patients afflicted with chronic pain have relied on traditional methods that often lacked customization and precision. Saluda’s technology, however, employs a sophisticated closed-loop system that allows the device to read and respond to the spinal cord's evoked compound action potentials (ECAPs) in real time. Such an approach offers a personalized therapy experience tailored to each patient's unique physiology, potentially leading to better outcomes.

The automating feature of the EVA™ Sensing Technology is particularly noteworthy. It effectively minimizes the often cumbersome manual programming steps associated with traditional therapies, allowing for a more efficient and precise delivery of treatment. By analyzing a patient’s spinal cord responses, it can deliver optimized therapy, reducing the guesswork clinicians usually face. As Barry Regan, CEO of Saluda Medical, stated, “This approval is in line with our expectations and builds on the successful commercialization we’ve seen in the U.S. This expansion allows us to bring a proven technology enhancement to more markets.”

The significance of this technology was echoed by Dr. Harold Nijhuis, a pain specialist at Antonius Hospital in the Netherlands, who highlighted the positive outcomes observed in patients compared to conventional open-loop therapy. The EVA™ Sensing Technology not only streamlines the programming processes but also maximizes analgesic benefits, thereby enhancing the overall patient experience. This dual emphasis on efficiency and improved outcomes underscores Saluda Medical’s commitment to innovation in pain management.

With the CE certification in hand, Saluda is poised to initiate a limited commercial rollout in Europe and Australia starting in the first quarter of 2026. A full commercial release is expected to follow later in the year. Saluda Medical’s strategic timing for this approval and subsequent launches aligns seamlessly with the company's internal plans to expand its market footprint.

Saluda Medical has previously made headlines for its clinical trials, including the landmark EVOKE study, which delivered outstanding results and was published in respected medical journals such as The Lancet Neurology. These studies demonstrated the efficacy of the Evoke System in providing superior pain relief compared to traditional stimulation therapies. As more data from ongoing studies emerge, it is clear that Saluda Medical is not only advancing technology but also contributing to essential research that validates its innovations in chronic pain management.

In summary, Saluda Medical’s achievement of CE certification for its EVA™ Sensing Technology paves the way for expanding its innovative solutions in treating chronic pain. As the company prepares for the next steps in its commercial strategy, it continues to prioritize patient care and the enhancement of therapeutic outcomes. This development is just one example of how technological advancements can transform patient experiences in the healthcare sector, and it sets a promising tone for the future of medical device innovation.