Questions and Answers - Getting DBS Therapy

Am I a candidate for Reclaim™ Deep Brain Stimulation Therapy for OCD?

Reclaim DBS is not right for everyone. Only a doctor experienced with Reclaim DBS can determine whether or not you are a candidate.
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What is a Humanitarian Device Exemption (HDE)?

A humanitarian use device (HUD) is an FDA classification covering medical devices for the treatment of conditions affecting fewer than 4000 new patients per year.

The FDA reviewed the safety of the device and determined that the probable health benefits outweigh the risks of injury or illness from its use. Efficacy of treatment, however, has not been established. Surgery to implant Reclaim DBS Therapy for OCD can only be performed in medical centers that specifically approve its use.

Is the operation painful?

There may be some discomfort during the initial stages of the surgery. However, your brain is not sensitive to pain. Your doctor may numb your scalp to minimize discomfort during the first stage of the procedure.

You may be placed under general anesthesia during the placement of the extensions and the neurostimulator.
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What is the typical length of hospitalization for tests, procedure, and recovery?

The length of hospitalization varies, but is often just a few days.
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How is the stimulation adjusted?

Your clinician programs your stimulation levels wirelessly. The process is a noninvasive way of adjusting stimulation to meet your symptom control needs.
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Does the Reclaim DBS System make any noise?

No.

Is it safe to have medical tests with the system implanted?

Consult your doctor before engaging in any medical treatment (for example, ultrasound, mammograms, electrocautery, or heart defibrillation). MRI, Electroconvulsive Therapy (ECT), Transcranial Magnetic Stimulation (TMS) and diathermy (deep heat treatment) should not be permitted under any circumstances. Refer to Important Safety Information for more information.

What is the cost of Reclaim DBS Therapy for OCD?

The total cost varies significantly. Please contact your provider for an estimate of the costs associated with Reclaim DBS Therapy.

Will my insurance cover Reclaim DBS Therapy?

Coverage for Reclaim DBS Therapy is typically made on a case-by-case basis by Medicare, Medicaid and private payers. Humanitarian Device Exemption (HDE) products are eligible for Medicare coverage if the treatment is provided by a site that has Institutional Review Board (IRB) approval. Please contact your insurance company to see if your health plan provides coverage.

Can other people see the components of the Reclaim DBS System?

Depending on your body build, the neurostimulator may be noticeable as a small bulge under the skin. It typically isn't noticeable under clothes. There also may be a slight bump on the top of your head, but it usually isn't visible under hair.

 

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• Getting DBS Therapy
• Is It Right for You?
• Your Healthcare Team
• Insurance Coverage
• Surgery: What to Expect
• Questions and Answers

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