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edwards introducer sheath
Edwards Lifesciences
Summary: The Edwards Introducer Sheath is a medical device used in vascular procedures, primarily for introducing catheters. Key evidence highlights its role in reducing vascular complications during transcatheter aortic valve implantation.
FDA Clearance Information
Pathway
510K
Number
K031087 ↗
Decision Date
April 24, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards Introducer Sheath was cleared by the FDA through the 510(k) pathway on April 24, 2003. It is manufactured by Edwards Lifesciences and classified as a Class 2 device.
What It Is
The Edwards Introducer Sheath is designed to facilitate the insertion of catheters into the vascular system. It is commonly used in procedures requiring vascular access, such as transcatheter aortic valve implantation.
Clinical Applications
This device is frequently utilized in interventional cardiology and vascular surgery, particularly in procedures like transcatheter aortic valve implantation where precise vascular access is critical.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2015 and 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Edwards Introducer Sheath is effective in facilitating catheter insertion with a reduced incidence of vascular complications. Its use in transcatheter aortic valve implantation has been associated with improved procedural outcomes.
Safety Profile
Reported complications include rare instances of vascular injury and embolization. However, the overall safety profile is favorable, with complications being infrequent and manageable.
Evidence Limitations
The evidence base is limited by the small number of large-scale RCTs. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Edwards Introducer Sheath?
The device is indicated for use in procedures requiring vascular access, such as transcatheter aortic valve implantation.
What outcomes have been reported in clinical studies?
Studies have reported effective catheter insertion with reduced vascular complications during procedures.
What complications have been reported?
Safety data indicate rare occurrences of vascular injury and embolization, with an overall favorable safety profile.
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.