OVERVIEW THE ELITE STUDY

FREQUENTLY ASKED QUESTIONS FOR THE ELITE STUDY

• What is a clinical trial?
• What is the goal of the ELITE study?
• How does the InterStim™ Micro system work?
• Who can participate in the ELITE study?
• What can I expect if I participate?
• Will I be paid for being in this study?
• How will my information be used?

WHAT IS A CLINICAL TRIAL?

A clinical trial is a voluntary research study conducted with patients to evaluate the safety or effectiveness of a new or existing medical treatment, drug, or device. The goal of a clinical trial is to find new or improved methods of treating, preventing, or diagnosing different medical conditions.

WHAT IS THE GOAL OF THE ELITE STUDY?

The goal of the ELITE study is to better understand how living with Medtronic’s InterStim™ Micro system impacts bladder or bowel control symptoms, and everyday life. The InterStim™ Micro system has already been FDA-approved and is commercially available for patients with bladder and bowel control issues.

Some of the symptoms, or changes that will be measured/tracked during this study include:

• Leaks
• Frequency
• Bowel movements
• Quality of life questionnaires

For a full description of the ELITE study, visit clinicaltrials.gov

Who can participate in the ELITE study?

Your study physician will assess if you are eligible for the ELITE study based on certain criteria.

YOU MAY BE ELIGIBLE IF:

• You are willing and able to receive treatment at one of our ELITE study locations.
• You are 18 years of age or older.
• You have tried other treatments and your doctor thinks you are a candidate for Medtronic bladder control or bowel control therapy delivered by the InterStim™ Micro system.
• You are willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol.

YOU ARE NOT ELIGIBLE IF:

• Your doctor does not recommend Medtronic bladder control or bowel control therapy delivered by the InterStim™ Micro system for you.
• You are a woman who is pregnant, or you are planning to become pregnant during the 2 years of the study.

What can I expect if I participate?

The ELITE study may last for up to two years. Below is a high-level summary of what you can expect if you participate in the study.

Note: As a volunteer participant, you can exit the study at any time.

SCREENING AND CONSENT

Before enrolling in the study, you will meet with a physician at one of our ELITE study locations. During this meeting, your physician will screen you to determine if you are eligible for the study. If your physician determines you are a good candidate to enroll, you will be asked to sign a consent form to participate.

TRIAL PERIOD

Once the study begins, you will be asked to track your symptoms related to bladder or bowel control for 3 to 7 days. If you are eligible after this initial tracking period, you will be scheduled for an InterStim™ evaluation. This will allow you to “try out” the treatment for 3 to 14 days before moving forward with long-term therapy.

LONG-TERM THERAPY

If you achieve success during your evaluation, your doctor may decide to move forward with long-term therapy. Long-term therapy includes receiving the implanted InterStim™ Micro device and tracking your symptoms over the course of a two-year period. You will be scheduled for regular appointments with your study physician throughout this phase of the study.

Note: Long-term therapy is completely adjustable, reversible, and full-body MRI eligible.*

Will I be paid for being in this study?

You will be paid for your time spent keeping a detailed diary, completion of questionnaires and other documentation, for your hours missed from work or other normal activities, transportation, and other related costs that may be incurred for your study participation and visits.

How will my information be used?

To participate in the study, you will need to sign a consent form and the Authorization to Use and Disclose Health Information. If you decide to participate in the study, Medtronic (including, its agents and contractors) and others who work with the study will see health information about you.

Medtronic will keep your health information confidential in accordance with all applicable laws and regulations. Any reports or publications about the study or any other research will not include your name or a description of you. Information received during the study will not be used to market to you; your name will not be placed on any mailing lists or sold to anyone for marketing purposes.