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gore dryseal sheath
W.L. Gore & Associates
Summary: The Gore DrySeal Sheath is a vascular access device used primarily in complex percutaneous interventions. Key evidence highlights its utility in facilitating transcatheter procedures, especially in challenging anatomical scenarios.
FDA Clearance Information
Pathway
510K
Number
K093791 ↗
Decision Date
March 22, 2010
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 March 22, 2010. 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 designed to provide a stable and secure vascular access during endovascular procedures. It features a hemostatic valve to minimize blood loss and is used to facilitate the introduction of various interventional devices.
Clinical Applications
Commonly used in procedures requiring large-bore vascular access, such as transcatheter valve replacements and complex coronary interventions. It is particularly useful in patients with challenging vascular anatomy.
Evidence Summary
The literature includes six studies ranging from 2020 to 2025, comprising case series and retrospective analyses. These studies explore the sheath's role in facilitating transcatheter procedures and its impact on procedural success.
Reported Outcomes
Published studies report that the Gore DrySeal Sheath effectively facilitates device delivery in complex vascular procedures, particularly in cases with severe tortuosity or calcification. It has been shown to improve procedural success rates in transcatheter pulmonary valve implantation and other interventions.
Safety Profile
Reported complications include potential vascular injury due to large sheath size and challenges in patients with severe vascular tortuosity. However, the sheath's design aims to minimize such risks by providing a stable access point.
Evidence Limitations
Current evidence is limited by the small sample sizes and retrospective nature of most studies. Further prospective research is needed to fully understand the long-term safety and efficacy of the Gore DrySeal Sheath 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 vascular access, such as transcatheter valve replacements.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates in complex interventions, particularly in cases with challenging vascular anatomy.
What complications have been reported?
Safety data indicate potential vascular injury risks, especially in patients with severe tortuosity, but the sheath's design helps mitigate these issues.
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.