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railway sheathless access system
Cordis
Summary: The Railway Sheathless Access System by Cordis is a device used for vascular access in complex coronary and peripheral interventions. Key evidence suggests feasibility and safety for distal radial artery access.
FDA Clearance Information
Pathway
510K
Number
K180081 ↗
Decision Date
April 18, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Railway Sheathless Access System was cleared by the FDA through the 510(k) pathway on April 18, 2018. Manufactured by Cordis, it is classified as a Class 2 device under product code DYB.
What It Is
The Railway Sheathless Access System is designed to facilitate vascular access without the need for a traditional introducer sheath. It is primarily used in percutaneous coronary interventions (PCI) and other endovascular procedures, allowing for reduced vessel trauma and potential complications.
Clinical Applications
Commonly used in scenarios requiring complex coronary interventions, the Railway system is particularly beneficial in patients with challenging vascular anatomy or when minimizing vascular trauma is critical. It is also employed in procedures involving distal radial artery access.
Evidence Summary
The available literature includes five studies, comprising various study types such as RCTs and case series, conducted between 2021 and 2022. These studies explore the device's feasibility, safety, and efficacy in clinical settings.
Reported Outcomes
Published studies report that the Railway Sheathless Access System is effective in facilitating complex coronary interventions, particularly through distal radial artery access. The system has been shown to reduce vascular complications and improve procedural success rates in challenging anatomical scenarios.
Safety Profile
Reported complications include potential for vascular spasm and pain, particularly when larger introducer sheaths are used. However, the device is generally considered safe with a favorable risk profile in the studied contexts.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore outcomes in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Railway Sheathless Access System?
The device is indicated for use in complex coronary and peripheral interventions, particularly when distal radial artery access is preferred.
What outcomes have been reported in clinical studies?
Studies have reported successful procedural outcomes with reduced vascular complications, particularly in complex coronary interventions.
What complications have been reported?
Safety data indicate potential for vascular spasm and pain, especially with larger introducer sheaths, but overall the device is considered safe.
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.