đź“Š Evidence-Based Reference
Via Microcatheter Size 17 via Microcatheter Size 21 via Microcatheter Size 27 via Microcatheter Size 33
Summary: The via microcatheter by Microvention is a device used in endovascular procedures, primarily for venous stenting. Key evidence highlights its application in various clinical scenarios, with studies focusing on its efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192135 ↗
Decision Date ?
December 24, 2019
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The via microcatheter received FDA clearance through the 510(k) pathway on December 24, 2019. It is manufactured by Microvention and classified as a Class II device under product code DQY.
What It Is
The via microcatheter is a medical device designed for use in endovascular procedures. It facilitates the delivery of therapeutic agents or devices to targeted vascular sites, particularly in venous stenting applications.
FDA-Cleared Indications
- Used for the selective delivery of diagnostic, therapeutic, or embolic materials and devices during endovascular procedures.
- Intended for percutaneous vascular access and navigation through the vasculature under imaging guidance.
- The specific anatomy, delivered material, and compatible devices depend on the labeling for the selected VIA Microcatheter size.
Clinical Applications
- Selective catheterization of peripheral or visceral blood vessels during endovascular procedures.
- Delivery of embolic materials or other therapeutic agents to a targeted vascular site when compatible with the selected catheter.
- Delivery of interventional devices through the catheter when the device and catheter size are compatible.
- Use as an access and delivery catheter during selected venous interventions, including procedures involving iliac or central veins.
Reported off-label uses
- Use in selected complex venous interventions beyond the specific anatomy or procedure described in the device labeling.
- Use for delivery of materials or devices in vascular territories not specifically identified in the applicable labeling.
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 7 studies, with a mix of RCTs, prospective, and retrospective analyses. These studies span from 2016 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report varied outcomes, including successful delivery of therapeutic agents and devices in endovascular procedures. The device has shown efficacy in enhancing procedural success rates in venous stenting applications.
Safety Profile
Reported complications include device-related technical challenges and minor procedural complications. However, the overall safety profile is consistent with similar endovascular devices.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more diverse patient populations. Further research is needed to establish long-term outcomes and comparative effectiveness against other devices.
Practical Considerations
- The VIA product family includes different sizes, including 17, 21, 27, and 33; the number generally identifies the catheter's approximate inner diameter in thousandths of an inch.
- Select the catheter based on the guidewire, delivery system, embolic material, or therapeutic device being used. Compatibility must be confirmed in the current instructions for use.
- The catheter is advanced through a vascular access sheath or guiding catheter under fluoroscopic imaging, usually with contrast injection to confirm position.
- Use requires trained clinicians familiar with percutaneous vascular procedures. Potential complications include vessel injury, bleeding, thrombosis, embolization, infection, and contrast-related reactions.
- MRI safety and conditions depend on the exact catheter and whether it remains in the patient. The current manufacturer labeling should be checked before MRI; an indwelling or unknown catheter should not be assumed to be MRI safe.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for via microcatheter?
The via microcatheter is indicated for use in endovascular procedures, particularly in venous stenting and the delivery of therapeutic agents.
What outcomes have been reported in clinical studies?
Studies have reported successful delivery and deployment of stents and therapeutic agents, with improved procedural success rates.
What complications have been reported?
Safety data indicates minor procedural complications and technical challenges, consistent with other endovascular devices.
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.