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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 06/10/2025
Study Name The Tether Vertebral Tethering System PAS
Device Name The Tether™ - Vertebral Body Tethering System
Clinical Trial Number(s) NCT02897453 
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2 yrs < 12 yrs, Adolescent: 13-18 yrs, Transit.Adolescent B(as adults): 18 yrs < 22 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 At least 193 patients 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.
Interim or Final Data Summary
Actual Number of Patients Enrolled Across 9 sites, 185 patients were actively enrolled. There will be a maximum N of 184 across the entire cohort, as one patient has yet to have their first erect visit, and are excluded from this report at this time.
Due to an updated protocol amendment regarding inclusion and exclusion criteria, patients not originally enrolled in the PAS cohort have been retrospectively added to the cohort following institutional guidelines and IRB permissions. The changed criteria were the removal of surgeon and site caps on enrollment, the removal of the requirement for a preoperative PFT, and the allowance of telemedicine visits, which allowed sites with out of town patients to add to their cohort.
Actual Number of Sites Enrolled 9 active sites
Patient Follow-up Rate Two patients at the MSH site were excluded from the study due to the discontinuation of the MSH site. The sponsor noted data quality issues such as late data and missed protocol visits.


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 04/03/2025 04/04/2025 Overdue/Received
6 year report 04/01/2026 04/01/2026 On Time
7 year report 04/01/2027    
final report 11/30/2027    


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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