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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Success in Comaneci-Assist Coils Embolization Surv


 
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General
Study Status Ongoing
522 Number / Requirement Number PS190001 / PSS001
Date Original Plan Accepted 08/06/2020
Date Current Plan Accepted 03/07/2023
Study Name Success in Comaneci-Assist Coils Embolization Surv
Device Name Comaneci embolization assist device
Root Document Number DEN170064 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study is a multicenter, single arm, open, prospective, postmarket safety surveillance in up to 30 US centers. The objective of the Postmarket Surveillance Plan is to assess safety and performance of Comaneci Embolization Assist Device as used in postmarket clinical practice in the U.S.
Surveillance is to continue until complete data on the deployment of 90 devices with complete 30-day patient status are obtained. No more than 13 subjects should be enrolled at each clinical center.
Study Population The Postmarket Sureveillance Study will include male or female patients with wide-necked ruptured and/or unruptured intracranial aneurysms that may require adjunctive assistance with coil embolization during the surgical procedure.

Inclusion Criteria:
In order to assure that the probable benefits outweigh the probable risks for the Comaneci Embolization Assist Device, as indicated in the IFU, the subjects must meet all of the following Inclusion criteria:
1. Patient has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils.
2. Patient is considered for treatment with coil embolization assisted by the Comaneci Device for wide-necked intracranial aneurysms with neck width less than or equal to 10 mm. A wide-necked intracranial aneurysm is defined by the neck width as = 4 mm or a dome-to-neck ratio < 2.
3. A signed informed consent by the patient or legally authorized representative.
Exclusion Criteria:
Patient should be treated by the Comaneci device in accordance with the approved device label. (i.e. doesn’t meet the contraindication criteria, as described in the IFU):
1. Patient with known hypersensitivity to nickel-titanium.
Sample Size 90 evaluable subjects
Key Study Endpoints Safety
• Periprocedural events*: Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.
• All adverse events at discharge and up to 30 days post procedure.
• Functional status at discharge and 30 days assessed using the modified Rankin Scale (mRS).

Secondary safety endpoint: evaluation of the extent of any relationship between adverse event rate to operator experience.
(*) Including vessel perforation or dissection, intracranial aneurysm rupture, stroke, hemorrhage, death, inability to deploy or remove the device, and coil entanglement

Effectiveness Outcome
• Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography (DSA).
• Successful intracranial aneurysm (IA) occlusion, that is a stable IA occlusion, measured by Raymond Roy classification I or II taken at 6 months (± 21d) post procedure without the need for re-treatment of the target IA, using DSA.
• Good clinical outcome- mRS shift @ 6 months (change @ 6 months from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis.
Follow-up Visits and Length of Follow-up 180 DAYS
Interim or Final Data Summary
Interim Results Safety Results
Safety data is summarized in Table 5, Appendix C (SAEs), D (non-SAEs), and E (severity and relatedness). See assessment below for more detail

Effectiveness Results
Effectiveness: Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography (DSA).
Actual Number of Patients Enrolled 55
Actual Number of Sites Enrolled 17
Patient Followup Rate A total of 55 subjects have been enrolled as of September 29, 2022. Two (2) subjects terminated early, one (1) subject lost to follow up, and one (1) subject withdrew consent. follow-up rate is above 90%. No concern.


Success in Comaneci-Assist Coils Embolization Surv Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 11/04/2020 11/06/2020 On Time
6 month report 05/06/2021 05/07/2021 On Time
12 month report 11/06/2021 11/08/2021 On Time
18 month report 05/06/2022 05/04/2022 On Time
2 year report 11/06/2022 11/03/2022 On Time
30 month report 05/24/2023 05/22/2023 On Time
36 month report 11/24/2023 11/17/2023 On Time
42 month report 05/24/2024 05/23/2024 On Time
4 year report 11/06/2024    


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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