đź“Š Evidence-Based Reference
Via Microcatheter via Plus Microcatheter
Summary: The via microcatheter via plus microcatheter by Sequent Medical is a Class 2 device cleared by the FDA for use in venous stenting. Key evidence highlights its application in complex endovascular procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K132652 ↗
Decision Date ?
December 20, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The via microcatheter via plus microcatheter was cleared by the FDA through the 510(k) pathway on December 20, 2013. It is manufactured by Sequent Medical and classified as a Class 2 device.
What It Is
The via microcatheter via plus microcatheter is a medical device designed for use in endovascular procedures, particularly for venous stenting. It facilitates the delivery of therapeutic agents or devices to targeted vascular sites.
FDA-Cleared Indications
- Use in percutaneous vascular procedures to access blood vessels and deliver compatible therapeutic devices or materials.
- The specific clinical indication depends on the cleared labeling and the configuration used; the provided FDA summary does not establish a specific indication for venous stenting.
Clinical Applications
- Catheter-based access to a selected vascular site during an image-guided endovascular procedure.
- Delivery of compatible devices or therapeutic materials through the catheter to a target vessel.
- Use during procedures requiring selective navigation through the vascular system.
Reported off-label uses
- Use for delivery of embolic materials or other therapeutic agents outside the device's specific cleared labeling may be considered off-label and should be evaluated 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 15 studies, encompassing various study types such as case reports and retrospective analyses, with publication years ranging from 2022 to 2025.
Reported Outcomes
Published studies report successful use of the device in complex endovascular procedures, including stent-assisted embolization and varicocele embolization. Outcomes indicate effective navigation and delivery capabilities, contributing to procedural success.
Safety Profile
Reported complications include device-related issues such as catheter or balloon shaft separation, which are rare but require effective retrieval techniques. No significant adverse events were consistently noted across studies.
Evidence Limitations
The evidence is limited by the variability in study design and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Practical Considerations
- Confirm the exact VIA or VIA PLUS model, catheter dimensions, working length, and compatible guidewire or delivery system before use.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for preparation, flushing, advancement, and device deployment.
- Compatibility depends on the inner diameter, outer diameter, shaft characteristics, and delivery requirements of the intended device or material.
- MRI safety is configuration-dependent. Review the current manufacturer labeling for MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
- As with other vascular catheters, potential complications include bleeding, hematoma, vessel injury, dissection, perforation, thrombosis, infection, embolization, and contrast-related reactions.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for via microcatheter via plus microcatheter?
The device is indicated for use in venous stenting and other endovascular procedures requiring precise delivery of therapeutic agents.
What outcomes have been reported in clinical studies?
Studies report successful navigation and delivery in complex procedures, with effective outcomes in stent-assisted embolization and varicocele embolization.
What complications have been reported?
Safety data indicate rare complications such as catheter or balloon shaft separation, which necessitate retrieval techniques to avoid surgical intervention.
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.