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Headway 27 Microcatheter
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 ?
510(k)
Number ?
K110813 ↗
Decision Date ?
August 5, 2011
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter-based access to the neurovascular system for interventional procedures.
- Delivery of diagnostic or therapeutic devices and materials during endovascular treatment, when used with compatible accessories.
- Use under fluoroscopic or other appropriate imaging guidance by trained physicians.
Clinical Applications
- Catheter-based access to cerebral and other neurovascular vessels during endovascular procedures.
- Delivery of compatible embolic agents, coils, or other therapeutic materials when the specific configuration is labeled for that use.
- Support of neurovascular interventions requiring a microcatheter, including selected aneurysm or arteriovenous malformation procedures when consistent with the product labeling and compatible devices.
Reported off-label uses
- Use as an intermediate or delivery microcatheter during mechanical thrombectomy for selected acute ischemic stroke procedures.
- Delivery of intra-arterial medications during selected neurointerventional procedures.
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, 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.
Practical Considerations
- The listed configuration is approximately 156 cm long, with a 2.6 Fr distal outer diameter and a 0.027-inch inner diameter; confirm the exact model and specifications before use.
- Compatibility depends on the guide catheter, guide sheath, microwire, embolic material, implant, and other accessories. Check the current manufacturer instructions for use and maximum compatible device dimensions.
- The catheter is advanced under fluoroscopic guidance using standard sterile technique. Avoid excessive force, sharp angulation, or manipulation against resistance because vessel injury or catheter damage can occur.
- MRI safety depends on the catheter's exact condition and labeling, including whether it remains in the patient. Do not assume MRI compatibility; consult the current manufacturer labeling before MRI.
- Contraindications, warnings, and precautions include inability to safely access the target vessel, significant vascular tortuosity or stenosis, suspected vessel injury, contrast-related risks, and patient factors that make the planned procedure unsafe.
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.