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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 ?
510(k)
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.
FDA-Cleared Indications
- Provide percutaneous access to the arterial vascular system through the radial artery.
- Facilitate placement and exchange of catheters or other interventional devices during diagnostic or therapeutic vascular procedures.
- Support vascular access for procedures in which radial-artery access is clinically selected by the treating physician.
Clinical Applications
- Radial-artery access for diagnostic cardiac catheterization and coronary angiography.
- Radial-artery access for selected percutaneous coronary interventions.
- Radial-artery access for selected neurointerventional procedures, including catheter-based treatment of head and neck vessels.
- Radial-artery access for other peripheral vascular procedures when the anatomy and device compatibility are appropriate.
Reported off-label uses
- Radial-artery access for selected embolization procedures, including uterine, prostate, visceral, bronchial, and gastrointestinal embolization, when performed with compatible catheters and other devices.
- Radial-artery access for selected carotid or other supra-aortic interventions.
- Distal radial or snuffbox access in selected patients, depending on the specific device design and local practice.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Device dimensions and working length must match the radial artery, access sheath or catheter system, and target anatomy; available sizes vary by product configuration.
- Use requires assessment of radial and ulnar circulation, vessel diameter, tortuosity, spasm risk, and the distance from the wrist to the treatment site.
- The device should be used with compatible guidewires, sheaths, catheters, and hemostasis equipment according to the product labeling.
- Potential access-site issues include bleeding, hematoma, radial-artery spasm, thrombosis or occlusion, infection, nerve irritation, and, rarely, hand ischemia or compartment syndrome.
- MRI safety depends on the specific components and whether any device remains in the patient; the exact product labeling should be checked before MRI. These devices are generally intended for temporary procedural use rather than long-term implantation.
Procedures that use this device
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.