SALUDA MEDICAL

Transforming patients’ lives with disruptive neuromodulation solutions


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Everything Changes…

THIS CHANGES EVERYTHING.

The Evoke® SCS System now has MRI labeling FDA approved for 1.5T full body and 3T head & knee MRI across the most implant locations in the industry.

This approval applies to all commercially implanted Evoke system patients in the United States as well as patients formerly enrolled in the ECAP Study.  The Evoke® System has been MRI-approved since 2019 in Europe, 2020 in Australia, and since 2022 for patients in the ECAP study, a U.S. IDE study with 300 patients enrolled.  

With this FDA approval, the Evoke System now has commercial MRI approval in all global regions where Saluda is currently active.*

Blue wave

Over 10 years of research unlocking the power of ONE TRILLION+ ECAPs to change the world of neuromodulation.

Saluda® is the first to directly measure the spinal cord’s physiologic response to stimulation. A 10+ year journey since the first ECAP measurement to transform the science and practice of SCS using Evoked Compound Action Potentials (ECAPs) to pioneer smart neuromodulation therapy. The Evoke® System listens and responds to each patient’s neural signature.1.

See how we have made objective measurement of neural activation a reality.  

Clinical superiority with the Evoke® System

The EVOKE Study is the first double-blinded, pivotal randomized clinical trial demonstrating the most enduring patient outcomes from a randomized clinical study in the history of SCS.1

Access to transformative care for patients.

A new Transitional Pass-Through Payment (TPT) for the Evoke System has been created by the Centers for Medicare and Medicaid Services, effective January 1, 2023. The TPT is a pathway to increase patient access to new and innovative technology. This allows Hospitals and Ambulatory Surgery Centers (ASCs) to receive additional payment for the use of this technology through a new Healthcare Common Procedure Coding System (HCPCS) device code (C1826), developed exclusively for closed-loop technology.

View the reimbursment center to learn more >

CMS Centers for Medicare & Medicad Services

Evoked Compound Action Potentials (ECAPs):
the spinal cord’s response to stimulation

We are pioneering the understanding of the spinal cord’s response to stimulation by being the first to directly measure ECAPs.1

  • ECAPs are used to measure the electrical activity in certain areas of the brain and spinal cord
  • For the first time in spinal cord stimulation, ECAP sensing allows physicians to objectively measure the spinal cord’s physiologic response to stimulation1

Today, we are using our ECAP-controlled SmartLoop™ technology to transform the lives of patients suffering from chronic pain

Men run

Empowering clinicians with an objective and physiologic measure of neural activation

  • Why is neural activation important? Neural activation drives the pain inhibition mechanism
  • Directly measuring ECAPs and automatically adjusting stimulation enables consistent neural activation
  • More consistent and accurate neural activation provides more consistent pain relief3

Potential Future Applications

“Not only would this (Saluda’s proprietary SmartLoop™ technology) be revolutionary for the field of spinal cord stimulation but it would also have broad application to the field of neuromodulation, including therapies such as vagal nerve, sacral nerve, and deep brain stimulation”3

We are are applying our ECAP-controlled SmartLoop™ solutions to the neurological disorders with the highest unmet need through focused research, development, and clinical studies*

*The Saluda Medical Evoke® System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs. Other treatment areas have not been submitted to nor approved by the FDA.

Auto-adjusting smart therapy

For chronic pain

The Evoke® System is the world’s first smart spinal cord stimulation (SCS) system for the treatment of chronic pain. Only Evoke® can directly measure ECAPs and auto-adjust stimulation 4+ million times per day to deliver consistent therapy.

See what unlocking the ECAP means for both physicians and patients.