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veripath peripheral guiding catheter
Advanced Cardiovascular Systems
Summary: The Veripath Peripheral Guiding Catheter is a device used for guiding interventions in peripheral vasculature. It is primarily used in venous stenting procedures. Key evidence highlights its role in reducing complications compared to other catheter types.
FDA Clearance Information
Pathway
510K
Number
K994229 ↗
Decision Date
February 25, 2000
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Veripath Peripheral Guiding Catheter was cleared by the FDA via the 510(k) pathway on February 25, 2000. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The Veripath Peripheral Guiding Catheter is designed to facilitate the navigation and placement of interventional devices within the peripheral vasculature. It is intended for use in procedures requiring precise catheter guidance, such as venous stenting.
Clinical Applications
This catheter is commonly used in clinical scenarios involving peripheral vascular interventions, particularly where venous stenting is indicated. It provides clinicians with enhanced control and precision during catheter-based procedures.
Evidence Summary
The available literature includes a variety of study types, such as randomized controlled trials and systematic reviews, with a focus on catheter-related complications. The studies span from 2022 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Veripath Peripheral Guiding Catheter is associated with a lower incidence of total complications compared to other catheter types, with a relative risk of 1.95. However, no significant differences were found in catheter-related bloodstream infections or thrombosis incidence.
Safety Profile
Reported complications include risks associated with catheter insertion, such as accidental arterial puncture and nerve-related injury. Strategies to minimize these risks have been discussed in the literature.
Evidence Limitations
The evidence is limited by the scarcity of randomized controlled trials specifically evaluating the Veripath Peripheral Guiding Catheter. Further research is needed to explore long-term outcomes and comparative effectiveness in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Veripath Peripheral Guiding Catheter?
The device is indicated for use in peripheral vascular interventions, particularly in procedures requiring venous stenting.
What outcomes have been reported in clinical studies?
Studies have reported a lower incidence of total complications with the use of this catheter, though no significant differences in bloodstream infections or thrombosis were noted.
What complications have been reported?
Safety data indicate potential complications such as accidental arterial puncture and nerve-related injury during catheter insertion.
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.