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headway 27 microcatheter
Microvention
Summary: The Headway 27 microcatheter, manufactured by Microvention, is primarily used in neurovascular procedures. It is FDA 510k cleared and has been evaluated in several studies highlighting its visibility and versatility in stroke thrombectomy.
FDA Clearance Information
Pathway 510K
Number K110813 ↗
Decision Date August 5, 2011
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Headway 27 microcatheter was cleared by the FDA through the 510k pathway on August 5, 2011. It is manufactured by Microvention and classified as a Class 2 device under product code DQY.
What It Is
The Headway 27 microcatheter is a neurovascular device designed for endovascular procedures. It features a 156 cm length, 2.6 Fr distal outer diameter, and 0.027 inches inner diameter, providing excellent visibility and maneuverability for stroke thrombectomy.
Clinical Applications
The Headway 27 microcatheter is commonly used in stroke thrombectomy procedures due to its ideal dimensions and visibility. It is also employed in the treatment of arteriovenous malformations and other neurovascular interventions.
Evidence Summary
The available literature includes four studies, ranging from 2014 to 2025, encompassing various study types such as retrospective and prospective analyses. These studies focus on the device's application in neurovascular procedures.
Reported Outcomes
Published studies report that the Headway 27 microcatheter provides excellent visibility and maneuverability, making it suitable for stroke thrombectomy. Its dimensions allow for effective navigation in neurovascular interventions, enhancing procedural success.
Safety Profile
Reported complications include potential issues with microcatheter stability and maneuverability in complex vascular anatomies. However, specific adverse events related to the Headway 27 microcatheter were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically evaluating the Headway 27 microcatheter. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Headway 27 microcatheter?
The Headway 27 microcatheter is indicated for use in neurovascular procedures, including stroke thrombectomy and treatment of arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies report that the Headway 27 microcatheter offers excellent visibility and maneuverability, contributing to successful neurovascular interventions.
What complications have been reported?
Reported complications include potential issues with microcatheter stability and maneuverability, though specific adverse events were not detailed in the studies.
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.