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edwards lifesciences percutaneous sheath introducers with oligon material
Edwards Lifesciences
Summary: The Edwards Lifesciences percutaneous sheath introducers are used for vascular access in interventional procedures. Key evidence includes its use in transcatheter aortic valve implantation.
FDA Clearance Information
Pathway
510K
Number
K030944 ↗
Decision Date
June 20, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared via the FDA 510(k) pathway on June 20, 2003. It is manufactured by Edwards Lifesciences and classified as a Class 2 medical device.
What It Is
The Edwards Lifesciences percutaneous sheath introducers are designed for vascular access, facilitating the introduction of catheters and other devices into the vasculature. They are made with Oligon material, enhancing flexibility and durability.
Clinical Applications
Commonly used in procedures requiring vascular access, such as transcatheter aortic valve implantation (TAVI) and other interventional cardiology applications. The device supports the introduction of larger catheters and devices.
Evidence Summary
The available literature includes two studies, one from 2016 and another from 2025. These studies explore the use of the device in specific interventional procedures, including TAVI.
Reported Outcomes
Published studies report the successful use of the Edwards Lifesciences sheath introducers in facilitating transcatheter aortic valve implantation. The device's expandable nature aids in the smooth introduction of large devices like the Edwards SAPIEN 3 aortic valve.
Safety Profile
Reported complications include rare instances of occluder embolization, as noted in the literature. The device is generally considered safe when used as intended, with complications being infrequent.
Evidence Limitations
The evidence is limited by the small number of studies and the specific contexts in which the device was evaluated. Further research is needed to explore broader applications and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Edwards Lifesciences percutaneous sheath introducers?
The device is indicated for vascular access in interventional procedures, such as transcatheter aortic valve implantation.
What outcomes have been reported in clinical studies?
Studies have reported successful use in TAVI, with the sheath facilitating the introduction of large devices like the Edwards SAPIEN 3 valve.
What complications have been reported?
Safety data indicate rare occurrences of occluder embolization, but overall, the device is considered safe with infrequent complications.
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.