ABOUT THE THERAPY: ESSENTIAL TREMOR DEEP BRAIN STIMULATION

Treating the symptoms of essential tremor

Deep brain stimulation has been shown to reduce tremor in the upper extremity that is associated with essential tremor.¹

Patients with mild tremor may cope for years without treatment. Symptoms can worsen and become severe. Essential tremor can make it difficult for people to keep working, stay independent, and do everyday activities. They often avoid social situations and become isolated, anxious, or depressed.

Usually medication is tried first. Medications do not help most people and can have intolerable side effects like sleepiness, dizziness, or thinking problems. Injection of botulinum toxin may provide temporary relief of head tremor, but tends to weaken the hands.²

If medications are not working adequately and the tremor constitutes a significant functional disability, deep brain stimulation may be an option.

Deep brain stimulation uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. Medtronic DBS Therapy is approved for unilateral stimulation in patients with essential tremor. The implanted system is programmed to customize therapy for the patient.

How It Works

For essential tremor, the target site is the ventral intermediate nucleus of the thalamus (Vim).

MEDTRONIC DBS SYSTEM

A lead is surgically implanted in the brain and connected to a neurostimulator implanted near the collarbone. The neurostimulator contains a small battery and computer chip programmed to send electrical pulses to control symptoms.

A clinician programming device is used to adjust the stimulation to best control the individual's symptoms while minimizing side effects. Periodic adjustments of the programming are a routine part of therapy.

A patient programming device gives patients some control over their settings, within physician-prescribed limits.

RISKS OF THE IMPLANT PROCEDURE

DBS Therapy requires brain surgery. Risks of brain surgery may include serious complications such as coma, bleeding inside the brain, stroke, seizures and infection. Some of these may be fatal. Once implanted, the system may become infected, parts may wear through the skin, and the lead or lead/extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen.

Benefits and Risks

REDUCES TREMOR

Medtronic DBS Therapy for essential tremor has been shown to reduce tremor in the upper extremity that is associated with essential tremor.¹

DBS Therapy is FDA-approved to treat disabling tremor in one upper extremity, one arm and hand. Usually the hand used most often is treated. DBS Therapy may help symptoms of essential tremor that happen with or without trying to move.

Clinical studies have shown that Medtronic DBS Therapy provides:¹

• Improved ability to do everyday activities
• Less tremor
• Less disability (as reported by the patients)

MR CONDITIONAL

Medtronic gives you the first safe^* access to MRI anywhere on the body for diagnosing health conditions in patients with deep brain stimulation. Eligible patients with Medtronic DBS Therapy may have an MRI scan anywhere on the body under certain conditions. Refer to MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions and instructions for use.

REVERSIBLE

Deep brain stimulation is reversible. Therapy may be turned off. The system components may be removed, in most cases, preserving options for future therapies and treatments.

RISKS OF DBS THERAPY

Placing the DBS system requires brain surgery, which could have serious and even fatal complications including coma, bleeding inside the brain, stroke, seizures, and infection. Once implanted, the system may become infected, parts may wear through the skin, and the lead and/or extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen. Medtronic DBS Therapy may also cause new or worsening neurological, psychiatric, or Parkinson’s-related symptoms.

In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.

This therapy is not for everyone. This therapy should not be used for patients who will be exposed to diathermy (deep heat treatment) or transcranial magnetic stimulation. Magnetic Resonance Imaging (MRI) should only be performed as described in the product labeling. The DBS system may interact with other medical devices and electromagnetic interference.

Healthcare professionals must review the product technical manual prior to use for detailed disclosure. For information refer to Indications, Safety, and Warnings or call Medtronic at 800-328-0810.