đź“Š Evidence-Based Reference
gore dryseal sheath
W.L. Gore & Associates
Summary: The Gore DrySeal Sheath is a vascular access device used primarily in complex endovascular procedures. Key evidence highlights its utility in facilitating transcatheter valve implantation and managing vascular tortuosity.
FDA Clearance Information
Pathway
510K
Number
K120428 ↗
Decision Date
April 20, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Gore DrySeal Sheath was cleared by the FDA via the 510(k) pathway on April 20, 2012. It is manufactured by W.L. Gore & Associates and is classified as a Class 2 medical device.
What It Is
The Gore DrySeal Sheath is a vascular access device designed to provide a stable and secure conduit for the delivery of endovascular devices. It is intended for use in procedures requiring large-bore access, such as transcatheter valve implantation.
Clinical Applications
Common clinical scenarios for the Gore DrySeal Sheath include transcatheter pulmonary valve implantation and managing challenging vascular anatomy, such as severe iliofemoral tortuosity, during high-risk percutaneous interventions.
Evidence Summary
The available literature includes six studies, comprising various study types such as case series and retrospective analyses, published between 2020 and 2025. These studies explore the sheath's application in complex endovascular procedures.
Reported Outcomes
Published studies report that the Gore DrySeal Sheath facilitates the delivery of transcatheter valves, such as the Edwards SAPIEN, in challenging anatomical conditions. It has been shown to aid in the protection of cardiac structures during valve deployment and improve procedural success rates in high-risk interventions.
Safety Profile
Reported complications include potential vascular injury due to large sheath size and challenges associated with severe vascular tortuosity. However, the sheath's design aims to minimize these risks by providing a stable conduit for device delivery.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of some analyses. Further research is needed to establish long-term outcomes and compare the sheath's performance with alternative devices in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Gore DrySeal Sheath?
The Gore DrySeal Sheath is indicated for use in endovascular procedures requiring large-bore access, such as transcatheter valve implantation and managing complex vascular anatomy.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful facilitation of transcatheter valve delivery and improved procedural success in challenging anatomical conditions.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and challenges with severe vascular tortuosity, though the sheath's design aims to mitigate these risks.
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.