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scimed triguide guide catheter
Scimed Life Systems
Summary: The Scimed Triguide Guide Catheter is a Class 2 medical device used in venous stenting procedures. Cleared by the FDA via the 510k pathway, it is supported by 10 peer-reviewed studies focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K944537 ↗
Decision Date
October 21, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed Triguide Guide Catheter was cleared by the FDA through the 510k pathway on October 21, 1994. It is manufactured by Scimed Life Systems and classified as a Class 2 device.
What It Is
The Scimed Triguide Guide Catheter is designed for use in venous stenting procedures. It facilitates the delivery of stents to targeted venous sites, aiding in the treatment of vascular conditions.
Clinical Applications
Commonly used in procedures involving venous stenting, the Scimed Triguide Guide Catheter is integral in interventions requiring precise stent placement. It is particularly useful in treating conditions like renal stenosis and pseudoaneurysms.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case reports, conducted between 1995 and 2018. These studies explore the catheter's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Scimed Triguide Guide Catheter effectively aids in the placement of stents, improving procedural outcomes in venous interventions. It has been shown to optimize procedural and clinical results in renal stenting and other vascular procedures.
Safety Profile
Reported complications include thrombus formation on guide wires during procedures, as noted in some studies. However, the catheter's design aims to minimize such risks through improved coatings.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the Scimed Triguide Guide Catheter. Further research is needed to establish long-term safety and efficacy outcomes across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Scimed Triguide Guide Catheter?
The device is indicated for use in venous stenting procedures, particularly in treating renal stenosis and pseudoaneurysms.
What outcomes have been reported in clinical studies?
Studies report improved procedural outcomes and optimized stent placement in venous interventions.
What complications have been reported?
Safety data indicate potential thrombus formation on guide wires, though the catheter's design seeks to mitigate this risk.
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.