#United States #Minneapolis #Chronic Pain #Saluda Medical #EVA

Saluda Medical's New Era in Chronic Pain Management

In a groundbreaking development for chronic pain management, Saluda Medical, Inc. has received FDA approval for EVA™, the first automated programming platform for spinal cord stimulation (SCS). This innovative platform is designed to significantly enhance the treatment experience for patients suffering from chronic neurological conditions, representing a substantial leap forward in SCS therapy.

Understanding EVA™ and Its Capabilities

The EVA™ platform is tailored for patients using the Evoke® Smart Loop System, already implanted in numerous individuals across the United States. One of the standout features of this platform is its automated patient programming process, which eliminates many manual programming steps traditionally required in SCS therapy.

EVA works by autonomously scanning and analyzing a patient’s nerve responses, using a response or feedback mechanism called evoked compound action potentials (ECAPs). This means that EVA can optimize therapy settings in real-time, adapting to the unique biomarker responses from each patient. As a result, the programming burden is drastically reduced, allowing for significantly improved patient experiences and increased efficiency within clinic operations.

Clinical Impact and Significance

The potential benefits of EVA™ are immense. According to Dr. Timothy Deer, President and CEO of The Spine and Nerve Center of the Virginias, the new automated programming workflow positions the Evoke System as a transformative force in the spinal cord stimulation sector. He highlighted how EVA facilitates faster, more consistent programming while allowing clinicians to access and monitor physiologic data to fine-tune therapeutic dosing.

Real-world applications have demonstrated that sophisticated therapy optimizations can occur in under 13 minutes. This efficiency is invaluable in busy pain management clinics, with the ability to improve patient outcomes while simultaneously increasing overall clinic throughput.

The clinical data supporting EVA’s efficacy will be showcased at the forthcoming North American Neuromodulation Society (NANS) Annual Meeting, set for January 30 to February 1, 2025, in Orlando, Florida. Insights from this conference will reveal more about how EVA impacts the patient programming experience, further solidifying its role in contemporary pain management practices.

A Closer Look at Saluda Medical

Saluda Medical is at the forefront of developing and commercializing neuromodulation technologies aimed at addressing chronic neurological disorders. Their closed-loop, dose-control platform is designed to sense and measure neural responses, automatically adjusting therapy based on real-time feedback. The initial product of this innovation, the Evoke System, provides spinal cord stimulation therapy for various hard-to-treat chronic conditions, including neuropathic pain following surgery or persistent lower back pain.

With promising results from multi-center clinical studies published in esteemed journals like The Lancet Neurology and JAMA Neurology, the Evoke System has demonstrated superior pain relief capabilities compared to traditional open-loop therapies. The data from these studies showcases the long-term efficacy of Saluda’s innovative approach to chronic pain management, highlighting sustained pain relief benefits over 36 months.

Conclusion

In summary, Saluda Medical’s introduction of the EVA™ programming platform marks a significant milestone in the management of chronic pain through spinal cord stimulation. By harnessing the power of automated, biomarker-based programming, EVA not only aims to lessen the burden on healthcare providers but also strives to improve the quality of life for patients dealing with the debilitating effects of chronic pain. As the medical community eagerly awaits further clinical insights, the future of chronic pain treatment looks brighter than ever before.