Saluda Medical is redefining the standard of care in spinal cord stimulation (SCS) with Evoke™ Therapy.
Evoke Therapy is the world’s first SCS therapy that uses real-time feedback from your nervous system to personalize treatment. It automatically adjusts stimulation over 4 million times per day to help interrupt pain signals before they reach the brain, helping improve comfort and consistency over time.
This means patients can try a minimally invasive pain management therapy, that can include a trial period before committing to an implant.
Learn more: saludamedical.com
Risks and Important Safety Info saludamedical.com/safety/
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U.S. Indications for Use: The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Failed back surgery syndrome, intractable low back pain and leg pain, diabetic peripheral neuropathy of the lower extremities. Contraindications: The Evoke System must not be used in patients who do not receive effective pain relief during trial stimulation, are unable to operate the system, or are unsuitable surgical candidates. Warnings: Sources of electromagnetic interference (e.g., diathermy, MRI, CT scans, electrosurgery, lithotripsy, external defibrillation, radiation therapy, ultrasonic scanning, high-output ultrasound, TENS, psychotherapeutic procedures, laser procedures) can interact with the system, resulting in unexpected changes in stimulation, serious patient injury or death. An implanted cardiac device (e.g., pacemaker, defibrillator) may damage a neurostimulator, and electrical pulses from the neurostimulator may cause inappropriate response of the cardiac device. The Evoke System has not been tested for use in patients who are pregnant or nursing nor in patients under 18 years old. Surgical complications and adverse events may be more frequent and severe in diabetic patients. The physiologic closed-loop controlled (PCLC) stimulation mode and frequencies greater than 1200 Hz have not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Precautions: Patients should avoid manipulating the Evoke System through the skin. Therapy should be discontinued immediately in the event of malfunction or failure of any component of the Evoke system. The severity of any surgical complication may be greater in diabetic patients, particularly those with inadequate pre-operative glycemic control. Potential Risks: Risks may include, but are not limited to epidural abscess, wound infection, lead breakage/fracture, lead migrations, IPG pocket pain, and muscle spasm or cramp.
