Clinical Study of a Laser Ablation Procedure for Drug-Resistant Epilepsy PARTICIPATION IN THE SLATE STUDY
You just clicked a link to go to another website. If you continue, you will leave this site and go to a site run by someone else.
It is possible that some of the products on the other site are not approved in your country.
Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. The content may not be approved for use in your specific region or country. Please review applicable product labeling for your country for indications and instructions prior to use. If not approved, please exit this site.
Click “Continue” to close this window and view the site’s content.
Your browser is out of date
With an updated browser, you will have a better Medtronic website experience. Update my browser now.
Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
Limited License Grant. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
) Your Personal Information. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America.
) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
Permissions. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software.
Your Acknowledgements. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patient’s implanted cardiac device data, including any data on the Programmer. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients.
Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
Reporting Issues and Feedback. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Any maintenance and support services provided by Medtronic shall be at Medtronic’s sole discretion.
Limitations of Liability.
THE LICENSED SOFTWARE IS PROVIDED TO YOU “AS IS,” AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE.
Legal Compliance. You shall at all times use the Licensed Software in compliance with all applicable laws. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
Term, Termination, Modifications, and Support. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Medtronic may modify, disable, or terminate your use or Medtronic’s support of the Licensed Software at any time, including by providing notices on a Medtronic website. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. At any time upon Medtronic’s request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. In addition, upon Medtronic’s request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction.
NayaMed International Sárl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Sárl. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses.
A clinical study of a laser ablation procedure for drug-resistant epilepsy is currently enrolling eligible patients who would like to participate. Centers participating in the study will research whether laser ablation is a safe and effective treatment option for certain patients with uncontrolled seizures caused by mesial temporal lobe epilepsy (MTLE).
The SLATE study will use the Medtronic VisualaseTM 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.
Visualase MRI-Guided Laser Ablation for Minimally Invasive Neurosurgery
Watch an overview animation of the procedure.
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:
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.
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:
You must be willing to:
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.
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.
Contact one of these study centers to see if you qualify and to learn more. Check back for additional updates on sites.
Palo Alto, CA
Casey Halpern, MD
Contact 1: Bharati Sanjanwala
Contact 2: Anthony Bet
University of California, San Francisco
San Francisco, CA
Robert Knowlton, MD
Contact: Felicia Kuo
University of Colorado Anschutz Medical Campus
Aviva Abosch, MD, PhD
Contact: Pamela David Gerecht, PhD
University of Miami
Jonathan Jagid, MD
Contact: Letitia Fisher
Jon T. Willie, MD, PhD
Contact: Yvan Bamps, PhD
Vicenta Salanova, MD
Contact: Abigail Klaehn, RN, BSN
Johns Hopkins University
Joon-Yi Kang, MD
Contact: Tony Stanfield or Joon-Yi Kang
Henry Ford Health System
Jason Schwalb, MD
Contact: Kelly M. Tundo, RN, BSN
Jamie Van Gompel, MD
Contact: Karla Crockett
Rutgers – Robert Wood Johnson Medical School
New Brunswick, NJ
Stephen Wong, MD MS
Contact: Asha Cilly, MSN, FNP-C
Columbia University Medical Center
New York, NY
Guy M. McKhann II MD
Contact: Gail Iodice
Great Neck, NY
Ashesh D. Mehta, MD. PhD
Contact: Connie Lau, MS, CCRC
Wake Forest Baptist Health
Gautam Popli, MD
Contact: Jessica P.
Thomas Jefferson University
Michael Sperling, MD
Contact: Leah Shabo
University of Texas Health Science Center at Houston
Nitin Tandon, MD
Contact: Jessica A Johnson,MSN, NP-C
University of Washington- Harborview Medical Center
John Miller, MD, PhD
Contact: Gina DeNoble, MS
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.
Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.