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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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HydroCoil Study


 
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General
Study Status Completed
522 Number / Requirement Number PS100001 / PSS001
Date Original Plan Accepted 05/31/2012
Date Current Plan Accepted 05/31/2012
Study Name HydroCoil Study
Device Name Microvention hydrocoil-soft-frame
Root Document Number K020434  K032590  K033836  K041551  K050954  K070656  K080666  K090357 
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Retrospective and prospective, multi-center, single arm study with two study groups
Study Population Adult 21+
Sample Size Group 1: A total of 324 patients from 4 studies/registries who were provided the HydroCoil device with a minimum of 18 months follow-up were analyzed for incidences of hydrocephalus and aseptic meningitis. Information from these patients was used as the primary analysis to address the 522 order. Group 2: A total of 488 patients from 6 published articles/registries who were provided the HydroCoil device with< 18 months or no follow-up were analyzed for incidences of hydrocephalus and aseptic meningitis. The related information was primarily obtained from the published literature and was summarized as supportive information only.
Key Study Endpoints Incidence of hydrocephalus; Incidence of aseptic meningitis; Aneurysm location; Aneurysm size; Number of HydroCoils and total number of coils deployed; HydroCoil length and total coil length. Based on the aneurysm size and coils used, the HydroCoil and total packing density will be calculated
Follow-up Visits and Length of Follow-up Data were collected for patients with a minimum of 18 months follow-up. This information was used for the primary analysis. Additional information was collected for patients with a minimum of < 18 months or no available follow-up. This group was not included in the primary analysis, but was summarized as supportive information only.
Interim or Final Data Summary
Actual Number of Patients Enrolled Group 1: 313 patients. Group 2: 488 patients
Actual Number of Sites Enrolled Group 1: not reported. Group 2: not reported
Patient Followup Rate Group 1: 97%
Group 2: not reported
Final Safety Findings 1) The unexplained hydrocephalus incidence 0.019 with a 95% CI of (0.0084, 0.039). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations. 2)The unexplained aseptic meningitis incidence is 0.0032 with a 95% CI of (0.00016, 0.017). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations. 3)There is no significant difference in terms of the HydroCoil packing density between patients with no hydropcephatus (66%) and patients with hydropcephatus (62%). However, there is significant difference regarding the number HydroCoil used and the HydroCoil length. The mean number of HydroCoil used in patients reported hydrocephalus (9.2) is twice as many as those used in patients without hydrocephalus (4.2). The average HydroCoil length in patients reported hydrocephalus (127 cm) is three times of that in patients without hydrocephalus (41 cm). 4) No statistical difference in hydrocephalus between the HydroCoil group and the control group was detected at the aneurysm location (Fisher Exact P-value=0.379 at Basilar tip; Fisher Exact P-value=0.463 at non-Basilar tip) or sizes (Fisher Exact P-value=0.354 for aneurysm>10mm; Fisher Exact P-value=0.498 for aneurysm between 5mm and10mm)
Final Effectiveness Findings 1) The unexplained hydrocephalus incidence 0.019 with a 95% CI of (0.0084, 0.039). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations.
2.) The unexplained aseptic meningitis incidence is 0.0032 with a 95% CI of (0.00016, 0.017). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations.
3) There is no significant difference in terms of the HydroCoil packing density between patients with no hydropcephatus (66%) and patients with hydropcephatus (62%). However, there is significant difference regarding the number HydroCoil used and the HydroCoil length. The mean number of HydroCoil used in patients reported hydrocephalus (9.2) is twice as many as those used in patients without hydrocephalus (4.2). The average HydroCoil length in patients reported hydrocephalus (127 cm) is three times of that in patients without hydrocephalus (41 cm).
4) No statistical difference in hydrocephalus between the HydroCoil group and the control group was detected at the aneurysm location (Fisher Exact P-value=0.379 at Basilar tip; Fisher Exact P-value=0.463 at non-Basilar tip) or sizes (Fisher Exact P-value=0.354 for aneurysm>10mm; Fisher Exact P-value=0.498 for aneurysm between 5mm and10mm)
Study Strengths and Weaknesses Strength: Retrospective and prospective analysis.
Weakness: the study is a single arm study against historical control. Patients in the treatment arm are derived from two separate clinical studies and prospectively followed. The rates of hydrocephalus (or aseptic meningitis) in patients treated with Bare Platinum Coil of the control arm were estimated from previous medical experience. Therefore, confounding factors cannot be well controlled in the single arm study and confounding bias could not be ruled out. Conclusion to be drawn from the study must be interpreted with caution.
Recommendations for Labeling Changes No




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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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