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    K Number
    K173352
    Device Name
    Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
    Manufacturer
    Concentric Medical, Inc.
    Date Cleared
    2018-02-15

    (113 days)

    Product Code
    POL,NRY
    Regulation Number
    882.5600
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K120961
    Why did this record match?
    Device Name :

    Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.

    2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

    3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age

    Device Description

    The Trevo Retriever family, including the Trevo ProVue and Trevo XP ProVue Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever has a hydrophilic coating to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded. Once half the retriever's length is inserted into the microcatheter, the insertion tool is removed. Retrievers have a modified proximal end that permits attachment of the Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining Guide Wire Extension to Retriever facilitates removal or exchange of a catheter while maintaining Retriever position in anatomy. After exchange has been completed, the extension can be detached.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Trevo Retriever, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list with specific thresholds. Instead, the study aims to demonstrate superior clinical outcomes for the treatment arm compared to the control arm across several endpoints. The success thresholds are defined within the study design.

    Performance Metric (Acceptance Criteria)Reported Device Performance (Treatment Arm vs. Control Arm)
    Primary Effectiveness:
    90-day Utility Weighted Modified Rankin Scale (UW-mRS): Posterior probability the Trevo thrombectomy increases expected scores relative to medical management alone, with a threshold for success of at least 0.986.Mean UW-mRS: 5.5 (Treatment) vs. 3.4 (Control)
    Posterior mean treatment benefit, core-adjusted: 2.0 (95% credible interval 1.1 to 3.0)
    Probability of superiority: > 0.9999
    90-day Dichotomized mRS (0-2 vs. 3-6) (Functional Independence): Success based on the same model and hierarchical fashion as UW-mRS.Functional Independence (mRS 0-2): 48.6% (Treatment) vs. 13.1% (Control)
    Posterior treatment benefit, core-adjusted: 32.8% (95% credible interval 21.1% to 44.1%)
    Probability of superiority: > 0.9999
    Primary Safety:
    Incidence of stroke-related mortality at 90 days: No significant difference between study arms.Treatment Arm: 15.9% (17/107) vs. Control Arm: 18.2% (18/99)
    Difference: -2.3% [-12.6%, 8.0%]
    p-value = 0.7126 (No significant difference)
    Secondary Effectiveness:
    Early Neurological Response (Day 5-7/Discharge): Defined as NIHSS drop of ≥ 10 points or NIHSS score of 0 or 1.Treatment Arm: 47.7% vs. Control Arm: 19.2%
    Mean Absolute Difference: 28.5% (16.2%, 40.7%)
    Risk Ratio: 2.5 (1.6, 3.9)
    **P-Value:
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