BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Coil-Assist Stent

    PMA: P180031 · Supplement: S006 · Decision Jun 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Intracranial Coil-Assist Stent
    Trade Name
    Neuroform Atlas® Stent System
    PMA Number
    P180031
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    QCA
    Generic Name
    Intracranial coil-assist stent
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 24, 2025
    Date Received
    August 12, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    PMA was approved on May 16, 2019 with the following conditions of approval:PMA Post-Approval Study: “Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas™ Stent System (ATLAS)”: The Office of Neurological and Physical Medicine Devices (Office of Health Technology (OHT) 5) will have the lead for this study initiated prior to device approval. The ATLAS study was conducted under investigational device exemption (IDE) G150006 and patients were consented to be followed for up to three (3) years post-operative. The 1-year follow-up data from the ATLAS study was used to support the approval of the subject PMA P180031. As part of the PMA post-approval study, the long-term follow-up from the ATLAS study can provide safety and effectiveness information on the durability and safety of treatment using the Neuroform Atlas Stent System up to 3 years post-operative. The pre-specified safety endpoint is the incidence of patients who experienced a major ipsilateral stroke or neurological death. The pre-specified effectiveness endpoint is the incidence of patients who had complete (100%) intracranial aneurysm occlusion (Raymond-Roy Class 1) without significant in-stent stenosis (> 50%) or retreatment of the target aneurysm. The incidence of all ischemic or hemorrhagic adverse events (i.e., ischemic and hemorrhagic, ipsilateral and contralateral, of all severities, at all times after enrollment, and of any duration, including transient ischemic attacks (TIAs)) should also be reported as part of the long-term safety analysis. Patients will be assessed at 2- and 3-years (within ± 6 months) post-operative with neurological exams conducted in person per the G150006 clinical study protocol. In addition, all new and ongoing adverse events will be recorded and adjudicated by the Clinical Events Committee per the approved G150006 clinical study protocol. Imaging assessment of intracranial aneurysm occlusion and in-stent stenosis will be performed after 1-year post-operative if imaging assessments will be performed as part of usual care.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QCA Intracranial Coil-Assist Stent