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headway 17 microcatheter
Microvention
Summary: The Headway 17 microcatheter is used for endovascular procedures, particularly in neurovascular interventions. Key evidence highlights its role in facilitating complex procedures like aneurysm coil embolization.
FDA Clearance Information
Pathway 510K
Number K083343 ↗
Decision Date December 4, 2008
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Headway 17 microcatheter was cleared by the FDA via the 510(k) pathway on December 4, 2008. It is manufactured by Microvention and classified as a Class 2 device.
What It Is
The Headway 17 microcatheter is a flexible, small-diameter catheter designed for navigating the intricate vasculature of the brain. It is primarily used in neurovascular interventions to deliver therapeutic agents or devices.
Clinical Applications
Commonly used in procedures such as aneurysm coil embolization and treatment of arteriovenous malformations. It is valued for its ability to navigate challenging vascular anatomy.
Evidence Summary
The literature includes a mix of study types such as in-vitro studies and case reports, with a total of 5 studies reviewed. The studies range from 2020 to 2025.
Reported Outcomes
Published studies report the Headway 17 microcatheter's effectiveness in facilitating the delivery of embolic agents and devices in neurovascular procedures. It has been used successfully in complex cases such as aneurysm coil embolization and treatment of vasospasm.
Safety Profile
Reported complications include challenges in microcatheter passage through certain stents, as noted in in-vitro studies. No significant adverse events directly attributed to the device were highlighted in the reviewed literature.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Headway 17 microcatheter?
The Headway 17 microcatheter is indicated for use in neurovascular interventions, including aneurysm coil embolization and treatment of arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies report successful delivery of embolic agents and devices in complex neurovascular procedures, with effective navigation of challenging vascular anatomy.
What complications have been reported?
Reported complications include difficulties in microcatheter passage through certain stents, as observed in in-vitro 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.