Important Safety Information

Consult product manuals prior to use.

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
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. Allergic reaction to system components may occur. 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.

Rx Only

Saluda and Evoke are registered trademarks of Saluda Medical Pty Ltd.

CLIN-MKT-007886 Rev 3.00