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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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PAS Registry Study for ExAblate 4000


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General
Study Status Delayed
Application Number /
Requirement Number
P150038 S006/ PAS001
Date Original Protocol Accepted 11/06/2020
Date Current Protocol Accepted 11/11/2022
Study Name PAS Registry Study for ExAblate 4000
Device Name ExAblate
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, multicenter, international single arm, observational post-approval registry study
Study Population Single-arm study of male and female patients at least 30 years old who plan to be treated for TDPD using the Exablate Neuro System and who meet the specific enrollment criteria
Sample Size 50 patients are planned for this registry study. From the protocol:
A total of 50 subjects will be enrolled. A t-test graph demonstrated that the power will be sufficient to determine any significant differences in long-term effectiveness at a=0.05. The graph showed that at 25 subjects, the number of subjects needed had plateaued. With an approximate average of an 8% dropout per year through Year 5, the remaining population is estimated to be approximately 30 subjects at year 5, which shows full power.
Key Study Endpoints From the protocol:
Safety Analysis
Safety will be evaluated through descriptive analysis of the incidence and severity of adverse events. Adverse events will be recorded and categorized according to severity, expectedness, and relationship to Exablate Neuro system thalamotomy procedure and/or disease progression. Results will be tabulated and reported as follows:
Post thalamotomy incidence and severity of adverse events (AEs).
Comparison of post thalamotomy incidence and severity adverse event rates to the prior Exablate study for ET (PMA #P150038), and TDPD earlier study (P150038/S006).
Comparison of post thalamotomy incidence and severity adverse
events rates to prior Deep Brain Stimulation (DBS) rates
Effectiveness Analysis
Effectiveness will be evaluated through descriptive analysis of ON medication CRST scores for tremor/motor, posture/rest, and level of
disability. Results will be presented as percent change from baseline to post thalamotomy study visits for all subjects where unilateral Exablate
thalamotomy was attempted.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results Safety Results
Table 5 below presents 13 events in seven of the 18 subjects. Eleven subjects had no adverse events (total subjects, 18). Three of the events were new this reporting period (bold highlight, insomnia and falls, which were related to Parkinson’s (insomnia and a transient PD related fall) and a Procedure Related fall per the investigator. Five events in four subjects were Mild in severity, five events were Moderate, three events in two subjects were Severe, all of which were reported in the previous semiannual reports, and no events were Life Threatening. There were no new Severe AEs in this reporting period. Seven out of 13 adverse events were either transient, resolving within three days or unrelated to the device or procedure. Three events were Thalamotomy related. The event of severe imbalance issues was reported five days post treatment and was reported in a previous semiannual report (as "Ambulatory Issues.")

Effectiveness Results
Although the sample size is still small, the CRST generally improved from Screening baseline. The mean Tremor-Motor score improved from 13.1 to 2.2 at Month 3; percent change improved 85% (Table 6 and Figure 1). Tremor as measured by posture and rest components also showed improvement (Tables 7 & 8, and Figures 2 & 3). The Part C mean score improved from 10.0 to 4.0 at Month 3 (Table 9 and Figures 4)). Percent change at Month 6 was 63%.
Actual Number of Patients Enrolled 18
Actual Number of Sites Enrolled 8
Patient Follow-up Rate The expected subjects of Mo1, Mo3, Mo6 and Mo12 are 18, 15, 9 and 5, respectively. The actual who has completed the follow-up visit are 17, 12, 9, 5.


PAS Registry Study for ExAblate 4000 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 06/16/2019 07/25/2019 Overdue/Received
interim report 12/16/2019 12/13/2019 On Time
interim report 06/15/2020 08/21/2020 Overdue/Received
interim report 12/15/2020 12/21/2020 Overdue/Received
interim report 12/15/2021 07/14/2021 On Time
interim report 08/17/2022 08/17/2022 On Time
interim report 12/15/2022 01/27/2023 Enrollment Milestone Met
interim report 06/16/2023 06/23/2023 On Time
interim report 12/15/2023 12/14/2023 On Time
interim report 06/15/2024 06/14/2024 On Time
interim report 12/15/2024 12/12/2024 On Time
interim report 06/16/2025    


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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