📊 Evidence-Based Reference
Triguide-Plus Guiding Catheter
Scimed Life Systems
Summary: The Triguide-Plus Guiding Catheter is used in venous stenting procedures. It is FDA-cleared and supported by 10 studies. Key findings highlight its efficacy in complex PCI scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K923245 ↗
Decision Date ?
February 12, 1993
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Triguide-Plus Guiding Catheter was cleared through the FDA 510(k) pathway on February 12, 1993. It is manufactured by Scimed Life Systems and classified as a Class 2 device.
What It Is
The Triguide-Plus Guiding Catheter is a medical device designed for use in venous stenting procedures. It facilitates the delivery of interventional devices to target sites within the vascular system.
FDA-Cleared Indications
- Percutaneous catheter use within the vascular system.
- Provides access and support for the delivery of interventional devices during endovascular procedures.
Clinical Applications
- Endovascular access for delivery of interventional devices.
- Catheter-based treatment of selected venous lesions when the catheter's labeled specifications and compatibility requirements are met.
- Use as a guiding catheter during procedures requiring stable vascular access and device support.
Reported off-label uses
- Use as a support catheter during selected complex coronary interventions, including chronic total occlusion procedures, has been described for guiding-catheter devices but should not be assumed to be covered by this device's labeling.
- Use in other vascular territories or with devices not specified in the manufacturer's labeling may occur in clinical practice but is off-label.
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 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2022 to 2024.
Reported Outcomes
Published studies report the Triguide-Plus Guiding Catheter as effective in facilitating complex PCI procedures, including chronic total occlusions. It is noted for its utility in sheathless approaches and magnetic actuation technologies for enhanced catheter control.
Safety Profile
Reported complications include potential radial trauma reduction with sheathless systems and challenges in catheter tip retrieval. Overall, the device is considered safe with proper technique.
Evidence Limitations
The evidence is limited by the small number of randomized controlled trials and the need for more longitudinal studies to assess long-term outcomes. Further research is needed to explore its full potential in diverse clinical settings.
Practical Considerations
- The available FDA record does not list the catheter's French size range, working length, tip configuration, guidewire requirements, or maximum compatible device diameter; confirm these details in the current manufacturer documentation before use.
- Use only with compatible guidewires, introducer sheaths, contrast agents, and interventional devices, following the instructions for use.
- Advance and manipulate the catheter under appropriate fluoroscopic or other validated imaging guidance to reduce the risk of vessel injury, dissection, perforation, thrombosis, or embolization.
- MRI safety is not established by the information provided here. Check the device labeling for MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
- Contraindications, anticoagulation requirements, and infection or access-site precautions should be assessed according to the manufacturer's labeling and the planned procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Triguide-Plus Guiding Catheter?
The Triguide-Plus Guiding Catheter is indicated for use in venous stenting procedures, particularly in complex PCI scenarios such as chronic total occlusions.
What outcomes have been reported in clinical studies?
Clinical studies have reported the catheter's efficacy in complex PCI, including its use in sheathless systems and magnetic actuation technologies.
What complications have been reported?
Reported complications include potential radial trauma reduction and challenges in catheter tip retrieval, with overall safety contingent on proper technique.
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.