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gore dryseal flex introducer sheath
W.L. Gore & Associates
Summary: The Gore DrySeal Flex Introducer Sheath is used in vascular procedures, particularly for transcatheter aortic valve replacement (TAVR). Key evidence highlights its use in managing hostile aortic anatomies.
FDA Clearance Information
Pathway
510K
Number
K160254 ↗
Decision Date
May 12, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Gore DrySeal Flex Introducer Sheath was cleared via the FDA 510(k) pathway on May 12, 2016. It is manufactured by W.L. Gore & Associates and classified as a Class 2 device.
What It Is
The Gore DrySeal Flex Introducer Sheath is a medical device designed to facilitate the insertion of catheters and other instruments into the vascular system. It is primarily used in endovascular procedures, such as TAVR, to provide a stable and flexible access route.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as TAVR, especially in patients with challenging aortic anatomies. It provides a secure and flexible pathway for the delivery of large devices through the femoral artery.
Evidence Summary
The literature includes four studies, comprising case reports and comparative analyses, published between 2024 and 2025. These studies evaluate the device's performance in high-risk vascular procedures.
Reported Outcomes
Published studies report that the Gore DrySeal Flex Introducer Sheath is effective in providing stable vascular access during TAVR, particularly in patients with complex aortic anatomies. The device's design facilitates the safe and efficient delivery of large devices, contributing to successful procedural outcomes.
Safety Profile
Reported complications include potential vascular or cerebrovascular complications in patients with hostile aortic anatomies. However, the use of the sheath has been associated with a reduction in these risks when compared to alternative methods.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Gore DrySeal Flex Introducer Sheath?
The device is indicated for use in vascular procedures requiring stable access, such as TAVR, particularly in patients with complex aortic anatomies.
What outcomes have been reported in clinical studies?
Studies report effective vascular access and successful procedural outcomes in high-risk patients undergoing TAVR.
What complications have been reported?
Safety data indicate potential vascular or cerebrovascular complications, though the sheath may reduce these risks compared to other methods.
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.