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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 Progress Adequate
522 Number / Requirement Number PS190001 / PSS001
Date Current Plan Accepted  
Study Name Success in Comaneci-assist Coils Embolization Surv
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 Design Description 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.
Study Population Description 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 = 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 Surveillance is to continue until complete data on the deployment of 120 devices with complete 30-day patient status are obtained.
Data Collection 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

Efficacy

• 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


Success in Comaneci-assist Coils Embolization Surv Schedule

Report 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    
18 month report 05/06/2022    
24 month report 11/06/2022    
final report 06/06/2023    


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