Clinical Study of a Laser Ablation Procedure for Drug-Resistant Epilepsy PARTICIPATION IN THE SLATE STUDY

ABOUT THE LASER ABLATION PROCEDURE

The SLATE study will use the Medtronic Visualase^TM MRI-guided laser ablation system.

The Visualase system is used to perform minimally invasive laser surgery on soft tissue in the body. For neurosurgery, a surgeon guides a thin laser fiber through a small hole into the brain. The laser heats up and destroys a defined area of abnormal brain tissue, minimizing risk of potential damage to surrounding healthy tissue.

The patient is in a magnetic resonance imaging (MRI) scanner throughout the process. This lets the surgeon see an image of the brain, the laser probe placement, and how much tissue is being heated up and destroyed during the procedure.

Visualase is currently considered an investigational device for treatment of drug-resistant MTLE. The FDA has cleared the use of Visualase in neurosurgery and other surgical specialties.

ELIGIBILITY

You may qualify to participate in this study if you have mesial temporal lobe epilepsy (MTLE) and uncontrolled seizures. Your epilepsy doctor may have told you about the study and may do some tests to see if you qualify for the study. You may be a candidate if:

• You are 18 or older.
• You still have uncontrolled epileptic seizures, even though you have tried at least two antiepileptic drugs.
• You have had at least 12 seizures in the last year.

To take the next step, please contact a study center for more information. Only a study doctor can decide if you are a candidate for the study.

WHAT THE STUDY INVOLVES

If you qualify for the study and you decide to participate after learning more about the study, you will go to a study center for several visits:

• Before the Visualase procedure, you will have mental and cognitive function tests and a magnetic resonance image (MRI) scan.
• You will have the Visualase procedure.
• You will return four times over 12 months for checkups, mental and cognitive function tests, and MRI scans.

You must be willing to:

• Take your antiepileptic drugs as prescribed.
• Complete a daily seizure diary.
• Complete the required testing and follow-up visits.

Medtronic will pay for the study device and any tests or procedures done just for the research study. However, you or your insurance company may be billed for any tests and procedures that are considered standard medical care.

ABOUT CLINICAL STUDIES

A clinical study is a research study that explores whether a medical strategy, treatment, or device is safe and effective for people. These studies are used to produce the best data available for healthcare decision making.

Clinical studies follow strict scientific standards. These standards protect patients and help produce reliable study results. The clinical study may find that a new strategy, treatment, or device improves patient outcomes, offers no benefit, or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care.

Important Safety Information

As with any medical device or procedure, serious and even life-threatening risks and side effects can occur. The risks of this investigational therapy are listed in the informed consent document that potential patients review before participating in the study.