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via microcatheter via plus microcatheter
Sequent Medical
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 510K
Number K132652 ↗
Decision Date December 20, 2013
Product Code DQY
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.
Clinical Applications
This device is commonly used in procedures requiring precise delivery of stents or embolic agents within the venous system. It is particularly useful in complex cases where navigation through tortuous vasculature is necessary.
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.
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.