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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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The Tether Vertebral Tethering System PAS


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General
Study Status Delayed
Application Number /
Requirement Number		 H190005 / PAS001
Date Original Protocol Accepted 01/13/2020
Date Current Protocol Accepted 06/04/2021
Study Name The Tether Vertebral Tethering System PAS
Device Name The Tether™ - Vertebral Body Tethering System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Objectives The objective is to assess the ongoing safety and probable benefit of The Tether in a registry population.The study design is a single-arm, prospective, multicenter cohort, registry study.
Study Population The study population is comprised of skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis who receive the device in the post market environment. There is no comparator group.
Sample Size A total of 200 study subjects will be enrolled
Key Study Endpoints The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery. The primary safety endpoints are serious adverse events (SAEs), and device- or procedure-related AEs.
Follow-up Visits and Length of Follow-up Patients will be followed through 60-months from the time of each patient's index surgery.


The Tether Vertebral Tethering System PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/31/2020 08/31/2020 On Time
1 year report 03/01/2021 03/01/2021 On Time
18 month report 08/31/2021 08/31/2021 On Time
2 year report 03/01/2022 03/11/2022 Overdue/Received
3 year report 03/31/2023 03/24/2023 On Time
4 year report 03/01/2024 03/25/2024 Overdue/Received
5 year report 03/01/2025    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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