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edwards percutaneous sheath introducer
Edwards Lifesciences
Summary: The Edwards Percutaneous Sheath Introducer is a medical device used for vascular access, primarily in transcatheter procedures. Key evidence highlights its application in transcatheter aortic valve implantation (TAVI) with minimal complications.
FDA Clearance Information
Pathway
510K
Number
K121185 ↗
Decision Date
August 22, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards Percutaneous Sheath Introducer was cleared through the FDA 510(k) pathway on August 22, 2012. It is manufactured by Edwards Lifesciences and classified as a Class 2 device.
What It Is
The Edwards Percutaneous Sheath Introducer is designed to facilitate vascular access during percutaneous procedures. It is commonly used in transcatheter aortic valve implantation (TAVI) to provide a conduit for device delivery.
Clinical Applications
This device is frequently used in scenarios requiring reliable vascular access, such as in transcatheter aortic valve implantation (TAVI) and other endovascular procedures. It is particularly useful in minimizing vascular trauma during device insertion.
Evidence Summary
The available literature includes four studies, ranging from 2010 to 2025, covering various aspects of the device's application. Study types include case series and other observational designs.
Reported Outcomes
Published studies report successful use of the Edwards Percutaneous Sheath Introducer in facilitating TAVI procedures, with minimal vascular complications. The device has been shown to support effective device delivery and procedural success.
Safety Profile
Reported complications include rare instances of vascular trauma and hemorrhage, as noted in the literature. Overall, the device is associated with a favorable safety profile in the context of its intended use.
Evidence Limitations
Current evidence is limited by the small number of studies and the observational nature of the available data. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Edwards Percutaneous Sheath Introducer?
The device is indicated for use in procedures requiring vascular access, such as transcatheter aortic valve implantation (TAVI).
What outcomes have been reported in clinical studies?
Studies have reported successful device delivery and procedural success in TAVI with minimal complications.
What complications have been reported?
Safety data indicate rare occurrences of vascular trauma and hemorrhage, but overall the device is considered safe for its intended use.
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.