đź“Š Evidence-Based Reference
headway 17 advanced microcatheter
Microvention
Summary: The Headway 17 Advanced Microcatheter by Microvention is a device used in neurovascular interventions, primarily for navigating complex vascular structures. Key evidence highlights its passability in stent-assisted procedures.
FDA Clearance Information
Pathway 510K
Number K101542 ↗
Decision Date August 6, 2010
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Headway 17 Advanced Microcatheter received FDA clearance through the 510(k) pathway on August 6, 2010. It is manufactured by Microvention and classified as a Class 2 device under product code DQY.
What It Is
The Headway 17 Advanced Microcatheter is designed for neurovascular interventions, allowing clinicians to navigate intricate vascular pathways. It is intended for use in procedures requiring precise catheter placement.
Clinical Applications
Commonly used in endovascular procedures, the Headway 17 Advanced Microcatheter is employed in scenarios such as embolization of arteriovenous malformations and stent-assisted coiling of aneurysms.
Evidence Summary
The available literature includes two studies, one from 2020 and another from 2025, focusing on the device's passability and use in embolization procedures. These studies provide insights into its clinical utility and limitations.
Reported Outcomes
Published studies report the Headway 17 Advanced Microcatheter's effectiveness in navigating through stents and its utility in embolization procedures. The device demonstrates reliable passability in experimental settings.
Safety Profile
Reported complications include potential difficulties in passing through stent struts, as highlighted in experimental evaluations. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale clinical trials. Further research is needed to assess long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Headway 17 Advanced Microcatheter?
The device is indicated for use in neurovascular interventions, such as embolization of arteriovenous malformations and stent-assisted coiling of aneurysms.
What outcomes have been reported in clinical studies?
Studies report effective passability through stents and utility in embolization procedures, demonstrating its clinical reliability.
What complications have been reported?
Safety data indicate potential passability issues through stent struts, but no specific adverse events were 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.