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transradial artery access devices
Teleflexmedical
Summary: Transradial artery access devices by Teleflexmedical are used for vascular interventions. Key evidence highlights their use in neurointerventions and cardiac catheterization with noted anatomical challenges.
FDA Clearance Information
Pathway
510K
Number
K112554 ↗
Decision Date
November 18, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on November 18, 2011. It is manufactured by Teleflexmedical and classified as a Class 2 device.
What It Is
Transradial artery access devices facilitate vascular access through the radial artery, primarily used in neurointerventions and cardiac catheterization. They offer an alternative to transfemoral access, aiming to reduce complications associated with femoral access.
Clinical Applications
Commonly used in procedures such as carotid artery stenting and coronary angiography, these devices are favored for their potential to reduce bleeding complications and improve patient comfort compared to femoral access.
Evidence Summary
The literature includes a mix of RCTs, prospective, retrospective, and case series studies, totaling 15 studies from 2020 to 2024. These studies explore the efficacy and safety of transradial access in various interventions.
Reported Outcomes
Published studies report that transradial access is effective for carotid artery stenting and coronary interventions, with some anatomical challenges noted in left internal carotid artery navigation. The left distal radial artery access shows feasibility and safety in cardiac catheterization.
Safety Profile
Reported complications include challenges with radial artery occlusion and navigation difficulties in certain anatomical conditions. The pulseless radial artery presents a higher risk for complications, necessitating alternative access strategies.
Evidence Limitations
Evidence gaps include limited large-scale RCTs and a reliance on single-center studies. Further research is needed to explore long-term outcomes and optimize techniques for challenging anatomical scenarios.
Frequently Asked Questions
What are the clinical indications for transradial artery access devices?
Indications include carotid artery stenting and coronary angiography, particularly in patients where femoral access poses higher risks.
What outcomes have been reported in clinical studies?
Studies report effective outcomes in carotid and coronary interventions, with noted anatomical challenges in left internal carotid artery navigation.
What complications have been reported?
Safety data indicate complications such as radial artery occlusion and navigation difficulties in certain anatomical conditions.
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.