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Headway 17 Microcatheter
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 ?
510(k)
Number ?
K083343 ↗
Decision Date ?
December 4, 2008
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use within the vascular system under imaging guidance.
- Delivery of therapeutic agents or interventional devices through the vasculature.
- Use in endovascular procedures requiring catheter access to selected blood vessels.
Clinical Applications
- Selective catheterization of blood vessels during endovascular treatment.
- Delivery of embolic materials or other therapeutic agents when compatible with the catheter and procedure.
- Navigation through complex vascular anatomy as part of a percutaneous vascular intervention.
Reported off-label uses
- Delivery of detachable coils or other embolization devices in neurovascular procedures when used outside the specific cleared labeling.
- Selective catheterization and delivery in treatment of arteriovenous malformations, depending on the device labeling, anatomy and operator technique.
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 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.
Practical Considerations
- The Headway 17 is a small-lumen microcatheter; the exact inner diameter, outer diameter, working length and compatible guidewire or delivery system should be confirmed in the current manufacturer instructions for use.
- It is typically advanced through a compatible guide catheter or intermediate catheter under fluoroscopic imaging, often with a microwire.
- Device selection depends on the target vessel, tortuosity, access route, required support and the device or embolic material being delivered.
- MRI safety and conditions should be verified in the current manufacturer labeling; do not assume that the catheter or any attached component is MR safe or MR conditional.
- Potential complications include vessel injury, dissection, perforation, thromboembolism, vasospasm, infection, bleeding and device entrapment. Contraindications and warnings are provided in the current instructions for use.
Procedures that use this device
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.