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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

HydroCoil Study


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General
522 Number / Requirement Number PS100001 / PSS001
Current Plan Approved 05/31/2012
Study Name HydroCoil Study
Root Document Number K020434  K032590  K033836  K041551  K050954  K070656  K080666  K090357 
General Study Protocol Parameters
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Retrospective and prospective, multi-center, single arm study with two study groups

Study Population Description 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.

Data Collection 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.

Final Study Results
Number of Patients Group 1: 313 patients. Group 2: 488 patients

Number of Sites Group 1: not reported. Group 2: not reported

Follow-up Rate Group 1: 97%

Group 2: not reported

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)

Effect 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)

Strengths & 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.

Label Changes No



HydroCoil Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/30/2012 12/14/2012 Overdue/Received
1 yr report 05/31/2013 06/03/2013 Overdue/Received
18 month report 11/29/2013 12/16/2013 Overdue/Received
2 yr report 05/31/2014 02/19/2014 On Time


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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