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scimed triguide guide catheters
Scimed Life Systems
Summary: The Scimed Triguide Guide Catheters are used in vascular interventions, primarily for guiding stents and other devices. Key evidence highlights their role in improving procedural outcomes in angioplasty.
FDA Clearance Information
Pathway
510K
Number
K953515 ↗
Decision Date
September 19, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed Triguide Guide Catheters were cleared by the FDA via the 510(k) pathway on September 19, 1995. Manufactured by Scimed Life Systems, they are classified as Class 2 devices.
What It Is
The Scimed Triguide Guide Catheters are designed to facilitate the placement of stents and other devices within the vascular system. They are used in procedures such as angioplasty to provide support and guidance.
Clinical Applications
These catheters are commonly used in interventional cardiology and radiology for procedures involving the placement of stents in coronary and peripheral arteries. They are essential in ensuring accurate device delivery.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, published between 1995 and 2018. These studies explore the catheter's performance in different clinical settings.
Reported Outcomes
Published studies report that the Scimed Triguide Guide Catheters enhance procedural success in angioplasty and stenting. They are associated with improved navigation and placement accuracy, contributing to better clinical outcomes.
Safety Profile
Reported complications include thrombus formation on guide wires, as noted in some studies. However, the overall safety profile is consistent with similar devices in its class.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the Scimed Triguide Guide Catheters. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Scimed Triguide Guide Catheters?
The catheters are indicated for use in vascular interventions, particularly for guiding stents and other devices during angioplasty and related procedures.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success and accuracy in device placement during angioplasty and stenting.
What complications have been reported?
Safety data indicate thrombus formation on guide wires as a potential complication, though the overall safety profile is favorable.
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.