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headway 27 microcatheter
Microvention
Summary: The Headway 27 microcatheter by Microvention is a versatile device used primarily in stroke thrombectomy. Key evidence highlights its ideal dimensions and visibility for neuroendovascular procedures.
FDA Clearance Information
Pathway 510K
Number K142449 ↗
Decision Date March 26, 2015
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Headway 27 microcatheter was cleared by the FDA via the 510(k) pathway on March 26, 2015. It is manufactured by Microvention and classified as a Class 2 device.
What It Is
The Headway 27 microcatheter is designed for neuroendovascular procedures, providing excellent visibility and maneuverability. It is intended for use in accessing and navigating the cerebral vasculature.
Clinical Applications
Commonly used in stroke thrombectomy, the Headway 27 microcatheter is suitable for procedures requiring precise navigation and stability within the cerebral arteries.
Evidence Summary
The available literature includes four studies, with publication years ranging from 2014 to 2025. These studies encompass various designs, including retrospective and prospective analyses.
Reported Outcomes
Published studies report that the Headway 27 microcatheter offers excellent visibility and dimensions for stroke thrombectomy, enhancing procedural success. Its design facilitates effective navigation and stability in neuroendovascular interventions.
Safety Profile
Reported complications include challenges in maneuvering through small peripheral vessel segments, as noted in studies focusing on similar devices. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence lacks comprehensive data on long-term outcomes and specific adverse events associated with the Headway 27 microcatheter. Further research is needed to evaluate its performance in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Headway 27 microcatheter?
The Headway 27 microcatheter is indicated for use in neuroendovascular procedures, particularly in stroke thrombectomy and accessing cerebral vasculature.
What outcomes have been reported in clinical studies?
Studies report that the Headway 27 microcatheter provides excellent visibility and dimensions for effective stroke thrombectomy.
What complications have been reported?
Reported complications include difficulties in maneuvering through small peripheral vessel segments, although specific adverse events 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.