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trapliner catheter
Vascular Solutions
Summary: The Trapliner catheter is a guide catheter extension used in percutaneous coronary interventions. It is primarily used to enhance support during complex procedures. Key evidence highlights its role in facilitating antegrade dissection and re-entry in chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K180088 ↗
Decision Date
April 4, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Trapliner catheter was cleared by the FDA through the 510(k) pathway on April 4, 2018. 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 provide additional support during percutaneous coronary interventions. It is intended to facilitate the delivery of interventional devices to target lesions, particularly in challenging anatomical scenarios.
Clinical Applications
The Trapliner catheter is commonly used in procedures involving chronic total occlusions and other complex coronary interventions. It is particularly useful in scenarios requiring enhanced guide catheter support and stability.
Evidence Summary
The available literature includes four studies, comprising case series and other study types, published between 2021 and 2024. These studies explore the device's utility in complex interventions and its associated outcomes.
Reported Outcomes
Published studies report that the Trapliner catheter effectively facilitates antegrade dissection and re-entry in chronic total occlusions. It has been shown to enhance procedural success rates in experienced centers. The device's role in supporting complex interventions is well-documented.
Safety Profile
Reported complications include instances of device fracture and retrieval challenges, as highlighted in case reports. The MAUDE database analysis provides insights into potential modes of failure, emphasizing the need for careful handling during procedures.
Evidence Limitations
The evidence is limited by the small number of studies and the predominance of case series, which may not fully capture the device's efficacy and safety profile. Further research is needed to establish long-term outcomes and optimize usage protocols.
Frequently Asked Questions
What are the clinical indications for Trapliner catheter?
The Trapliner catheter is indicated for use in percutaneous coronary interventions, particularly in complex cases requiring enhanced guide catheter support.
What outcomes have been reported in clinical studies?
Studies have reported successful facilitation of antegrade dissection and re-entry in chronic total occlusions, with improved procedural success rates.
What complications have been reported?
Safety data indicate complications such as device fracture and retrieval challenges, as noted in case reports and database analyses.
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.