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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 ?
510(k)
Number ?
K953515 ↗
Decision Date ?
September 19, 1995
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for percutaneous access to the vascular system during diagnostic or therapeutic interventions.
- Used to guide, support, and facilitate the placement of compatible catheters, guidewires, stents, and other interventional devices.
- Intended for use in vascular procedures where controlled device delivery through a guide catheter is required.
Clinical Applications
- Providing support for delivery of intravascular devices during angioplasty and stent procedures.
- Guiding compatible devices through selected arterial or venous segments.
- Supporting endovascular treatment of peripheral vascular disease.
- Supporting catheter-based treatment of iliac or central venous obstruction when compatible with the planned intervention.
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.
Practical Considerations
- The record provided does not specify the available catheter lengths, French sizes, tip configurations, or maximum guidewire compatibility; these details must be confirmed in the product labeling.
- The catheter should be used only with compatible guidewires, catheters, stents, and other devices, while maintaining sterile technique and continuous imaging guidance.
- Patient anatomy, vessel diameter, access route, tortuosity, calcification, and the planned device can affect catheter selection and performance.
- MRI safety should not be assumed from the FDA clearance record. Confirm MR Safe, MR Conditional, or MR Unsafe status in the manufacturer’s labeling before MRI.
- Potential catheter-related complications include vessel injury, dissection, perforation, thrombosis, embolization, bleeding, infection, vasospasm, and contrast-related reactions.
Procedures that use this device
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.