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trapliner catheter
Vascular Solutions
Summary: The Trapliner Catheter by Vascular Solutions is a guide catheter extension used in percutaneous coronary interventions. Key evidence highlights its role in facilitating complex procedures with some reported complications.
FDA Clearance Information
Pathway
510K
Number
K161901 ↗
Decision Date
February 3, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Trapliner Catheter was cleared by the FDA through the 510(k) pathway on February 3, 2017. It is manufactured by Vascular Solutions and classified as a Class 2 device.
What It Is
The Trapliner Catheter is a guide catheter extension designed to enhance support during percutaneous coronary interventions. It is intended for use in complex coronary procedures, providing additional stability and access.
Clinical Applications
Commonly used in scenarios requiring enhanced guide catheter support, such as chronic total occlusions and other challenging coronary interventions. It aids in facilitating antegrade dissection and re-entry techniques.
Evidence Summary
The literature includes four studies ranging from 2021 to 2024, comprising case series and other study types. These studies explore the device's application in complex coronary interventions.
Reported Outcomes
Published studies report the Trapliner Catheter's efficacy in facilitating complex coronary procedures, particularly in chronic total occlusions. It has been shown to provide necessary support for successful interventions.
Safety Profile
Reported complications include instances of catheter fracture and retrieval challenges, as highlighted in case reports. These events underscore the need for careful handling and monitoring during use.
Evidence Limitations
The current evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for Trapliner Catheter?
The Trapliner Catheter is indicated for use in percutaneous coronary interventions requiring enhanced guide catheter support, such as chronic total occlusions.
What outcomes have been reported in clinical studies?
Studies have reported successful facilitation of complex coronary procedures, particularly in cases of chronic total occlusions.
What complications have been reported?
Safety data indicate complications such as catheter fracture and retrieval challenges, necessitating careful procedural management.
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.