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transgate guide catheter
Stryker Neurovascular
Summary: The Transgate Guide Catheter is a neurovascular device used primarily in mechanical thrombectomy procedures. Key evidence highlights its utility in emergent large vessel occlusion strokes.
FDA Clearance Information
Pathway
510K
Number
K132542 ↗
Decision Date
November 15, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Transgate Guide Catheter was cleared by the FDA via the 510(k) pathway on November 15, 2013. It is manufactured by Stryker Neurovascular and classified as a Class 2 device.
What It Is
The Transgate Guide Catheter is designed for neurovascular interventions, particularly in facilitating access to cerebral vasculature during mechanical thrombectomy. It aids in the delivery of therapeutic devices to the target site.
Clinical Applications
Commonly used in the treatment of acute ischemic stroke due to large vessel occlusion, the Transgate Guide Catheter assists in the navigation and support of other endovascular devices during neurointerventional procedures.
Evidence Summary
The literature includes 10 studies, encompassing retrospective analyses and reviews, with a focus on neuroendovascular applications. The studies span from 2021 to 2024, involving various clinical scenarios.
Reported Outcomes
Published studies report that the Transgate Guide Catheter is effective in facilitating mechanical thrombectomy, with successful navigation and device delivery in complex neurovascular procedures. Its use has been associated with improved procedural outcomes in stroke management.
Safety Profile
Reported complications include potential risks associated with endovascular procedures, such as vascular injury or device-related issues. However, specific adverse events related to the Transgate Guide Catheter were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and a lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for Transgate Guide Catheter?
The device is indicated for use in neurovascular interventions, particularly in mechanical thrombectomy for acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of mechanical thrombectomy and improved procedural outcomes in stroke management.
What complications have been reported?
Safety data from evidence indicate potential risks such as vascular injury, but specific complications related to the device were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.