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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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MID-C System Registry PAS


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General
Study Status Study Pending
Application Number H170001 / PAS001
Date Current Protocol Accepted 10/23/2019
Study Name MID-C System Registry PAS
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, Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study to evaluate the continued safety and probable benefit of the MID-C System in commercial use.
Study Population Description Adolescent patients with adolescent idiopathic scoliosis (AIS) for treatment of single curves classified as Lenke 1 (thoracic major curve) or Lenke 5 (thoracolumbar/lumbar major curve), having a Cobb angle of 45 to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from T5-T12.
Sample Size Patients implanted with the device in the US within 2 years of FDA’s approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study, with at least 50 patients enrolled by 24 months, 100 patients enrolled by 36 months, and 200 patients enrolled by 48 months. All patients who are implanted with the MID-C System at a participating site in the US will be asked to participate, unless the patient is seeking treatment at a site where the maximum site enrollment has been reached, until 200 patients are enrolled in the study. This study will include a minimum of 10 centers with sequential enrollment from each site that agrees to participate.
Data Collection Safety Endpoints

Primary: Serious adverse events, and device or procedure related adverse events

Secondary:

1. Rate of adverse events, including by relatedness to device or procedure and severity; and

2. Rate of reoperation, including by type of reoperation.



Probable Benefit Endpoints

Primary: Maintenance of major Cobb angle less than or equal to 40° 5 years post-surgery

Secondary: Annual analysis up to 5 years of the following:

1. Maintenance of major Cobb angle less than or equal to 40°

2. Curve progression no more than 10° of the secondary curve above or below the implant.

3. Composite endpoint analysis (maintenance of major Cobb angle less than or equal to 40° AND freedom from SAEs during MID-C procedure and procedure/device related SAEs following surgery).

4. True failure rate analysis. True failure is defined as conversion to another spinal implant OR major Cobb angle that exceeded 40° at defined follow-up visit OR any curve progression at defined follow-up compared to baseline OR death, OR permanent disability.

Follow-up Visits and Length of Follow-up Pre-op, Immediate Post-op up to 6 weeks, Post-op 6 Months (± 2 Months), Post-op 12 Months (± 3 Months), and Post-op Annually thereafter (± 3 Months) until 5 years of individual follow-up.


MID-C System Registry PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/21/2020 02/25/2020 Overdue/Received
one year report 08/22/2020    
18 month report 02/20/2021    
two year report 08/22/2021    
three year report 08/22/2022    
four year report 08/22/2023    
five year report 08/21/2024    


Contact Us

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

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