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Headway 17 Advanced Microcatheter
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 ?
510(k)
Number ?
K101542 ↗
Decision Date ?
August 6, 2010
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for percutaneous access and navigation within the vascular system during endovascular procedures.
- Intended to facilitate the placement of compatible interventional devices or therapeutic materials at a target site.
- FDA clearance was granted through the 510(k) pathway under product code DQY for a Class II percutaneous catheter.
Clinical Applications
- Selective catheterization and navigation of blood vessels during neurovascular interventions.
- Delivery of compatible embolic materials or devices when indicated by the specific procedure and device labeling.
- Catheter support during endovascular treatment of vascular abnormalities, when used according to the cleared labeling and instructions for use.
Reported off-label uses
- Off-label delivery of selected liquid embolic agents or other materials in neurovascular embolization procedures, depending on the specific catheter configuration and material compatibility.
- Off-label use as an access or delivery catheter in vascular territories outside the labeled indication, as determined by the treating physician.
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 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.
Practical Considerations
- The Headway 17 is a microcatheter intended for use with a compatible guidewire and guiding catheter or sheath; exact compatibility depends on the model and instructions for use.
- Available catheter length, distal-tip configuration, and inner-diameter specifications should be confirmed before the procedure because these affect device delivery and vessel access.
- Use requires fluoroscopic or other appropriate imaging guidance and careful control to reduce the risk of vessel injury, dissection, perforation, thrombus, or vasospasm.
- MRI conditions are model- and labeling-specific. Confirm the current instructions for use before exposing a retained or indwelling catheter to an MRI scanner; the device is generally used during an interventional procedure rather than left implanted.
- Potential contraindications and precautions include unsuitable vessel anatomy, severe vasospasm, inability to obtain safe vascular access, incompatibility with the intended therapeutic material, and patient-specific bleeding or clotting risks.
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.