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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
510K
Number
K923245 ↗
Decision Date
February 12, 1993
Product Code
DQY
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.
Clinical Applications
Commonly used in percutaneous coronary interventions (PCI), the Triguide-Plus Guiding Catheter is essential in procedures requiring precise navigation and support, such as chronic total occlusions and complex lesion access.
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.
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.