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Headway 27 Microcatheter
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 ?
510(k)
Number ?
K142449 ↗
Decision Date ?
March 26, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Catheter, percutaneous, for use in the peripheral and cerebral vasculature.
- Intended to facilitate the introduction of interventional devices into the peripheral and cerebral vasculature.
Clinical Applications
- Selective catheterization of cerebral arteries during neuroendovascular procedures.
- Navigation through tortuous vascular anatomy to deliver compatible interventional devices.
- Use as an access and delivery catheter during procedures involving the cerebral vasculature.
- Percutaneous catheter-based procedures in the peripheral vasculature when the catheter's labeled size and compatibility are appropriate.
Reported off-label uses
- Delivery of aspiration or adjunctive devices during mechanical thrombectomy for acute ischemic stroke, when used outside the specific cleared labeling or with a non-labeled technique.
- Delivery of embolic agents or other materials in selected neurovascular embolization procedures, when not specifically covered by the device labeling.
- Use in selected peripheral or venous interventions as a support or delivery catheter, based on operator judgment and device compatibility.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The Headway 27 is a small-lumen microcatheter; operators should confirm compatibility with the intended guidewire, guide catheter, aspiration system, stent retriever, embolic material, and other accessories before use.
- It is advanced over a guidewire under fluoroscopic imaging. Avoid forceful advancement, excessive torque, or resistance, which can contribute to vessel injury, catheter damage, or separation.
- The device is intended for single use and should be inspected before use. It should not be reused, resterilized, or used if the package is damaged.
- MRI safety depends on the exact device configuration and the presence of other implanted or retained components. Consult the current manufacturer instructions for use and MR labeling rather than assuming the catheter is MR safe.
- Contraindications, warnings, and limitations in the current FDA-cleared labeling and manufacturer instructions should be reviewed before use; risks include bleeding, vessel perforation or dissection, thromboembolism, infection, vasospasm, and catheter-related complications.
Procedures that use this device
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.