đź“Š Evidence-Based Reference
scimed triguide guiding catheter
Scimed Life Systems
Summary: The Scimed Triguide Guiding Catheter is used in venous stenting procedures. It is FDA-cleared and supported by clinical studies. Key evidence highlights its application in minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K941137 ↗
Decision Date
June 22, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed Triguide Guiding Catheter was cleared by the FDA through the 510(k) pathway on June 22, 1994. It is manufactured by Scimed Life Systems and classified as a Class 2 device.
What It Is
The Scimed Triguide Guiding Catheter is a medical device designed to facilitate the placement of stents in venous procedures. It is used by clinicians to guide other instruments to the target site within the vascular system.
Clinical Applications
This device is commonly used in procedures involving venous stenting, such as renal percutaneous transluminal angioplasty and stenting. It provides a pathway for other instruments to reach the site of intervention.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series, with publication dates ranging from 1995 to 2018.
Reported Outcomes
Published studies report that the Scimed Triguide Guiding Catheter is effective in facilitating minimally invasive stenting procedures. It has been shown to improve procedural outcomes in renal and coronary interventions. The catheter's design aids in precise placement and stability during interventions.
Safety Profile
Reported complications include thrombus formation on guide wires during procedures, as noted in some studies. However, the device's coatings are designed to reduce thrombogenicity, enhancing safety during use.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term outcomes and to compare its efficacy with newer devices.
Frequently Asked Questions
What are the clinical indications for Scimed Triguide Guiding Catheter?
The device is indicated for use in venous stenting procedures, particularly in renal and coronary interventions.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural outcomes and effective stent placement in minimally invasive interventions.
What complications have been reported?
Safety data indicate potential thrombus formation on guide wires, though device coatings aim 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.