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guideliner v3 catheter
Vascular Solutions
Summary: The Guideliner V3 catheter, manufactured by Vascular Solutions, is used to facilitate complex coronary interventions. It was FDA-cleared via the 510k pathway in 2017. Key evidence includes studies on its use in challenging anatomical scenarios.
FDA Clearance Information
Pathway
510K
Number
K172090 ↗
Decision Date
October 20, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guideliner V3 catheter was cleared by the FDA through the 510k pathway on October 20, 2017. It is manufactured by Vascular Solutions and classified as a Class 2 device under product code DQY.
What It Is
The Guideliner V3 catheter is a guide catheter extension designed to provide deep intubation support during percutaneous coronary interventions. It is intended to enhance the delivery of interventional devices to distal coronary lesions.
Clinical Applications
The Guideliner V3 catheter is commonly used in scenarios involving complex coronary anatomy, such as tortuous vessels or chronic total occlusions. It aids in the delivery of stents and other devices to challenging lesion sites.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2016 to 2019. These studies encompass various methodologies, including retrospective reviews and case reports, focusing on the device's application and safety.
Reported Outcomes
Published studies report that the Guideliner V3 catheter facilitates successful delivery of interventional devices in complex coronary procedures. It is particularly noted for its utility in challenging anatomical situations, such as distal lesions and tortuous vessels.
Safety Profile
Reported complications include potential vessel trauma due to deep intubation and the risk of dissection. However, modifications in the V3 version aim to reduce such risks compared to its predecessor.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the Guideliner V3 catheter.
Frequently Asked Questions
What are the clinical indications for Guideliner V3 catheter?
The Guideliner V3 catheter is indicated for use in percutaneous coronary interventions, particularly in complex cases involving distal lesions or tortuous vessels.
What outcomes have been reported in clinical studies?
Studies have reported successful delivery of interventional devices in complex coronary procedures, with a focus on challenging anatomical scenarios.
What complications have been reported?
Safety data indicate potential complications such as vessel trauma and dissection, though design improvements in the V3 version aim to mitigate these risks.
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.