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gore introducer sheath with silicone pinch valve
W.L. Gore & Associates
Summary: The Gore Introducer Sheath with Silicone Pinch Valve is a medical device used primarily in endovascular procedures to facilitate the insertion of other devices into blood vessels. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K032073 ↗
Decision Date
August 13, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Gore Introducer Sheath with Silicone Pinch Valve was cleared via the FDA 510k pathway on August 13, 2003. It is manufactured by W.L. Gore & Associates and is classified as a Class 2 device under product code DYB.
What It Is
The Gore Introducer Sheath with Silicone Pinch Valve is a specialized introducer sheath designed to provide a conduit for the insertion of catheters and other devices into the vascular system. It features a silicone pinch valve that helps minimize blood leakage during procedures. This device is particularly useful in maintaining hemostasis while allowing for the passage of multiple instruments.
Clinical Applications
This device is commonly used in procedures such as endovascular aneurysm repair (EVAR) and fenestrated endovascular aneurysm repair (fEVAR), where multiple catheters or stents need to be introduced into the vascular system. It is typically utilized in settings such as interventional radiology suites and vascular surgery operating rooms. The device is suitable for adult patients undergoing complex vascular interventions.
Indications for Use
The FDA indications suggest that this sheath is intended for use in endovascular procedures where maintaining hemostasis is critical. It is particularly beneficial for patients undergoing procedures that require the insertion of multiple devices into the vascular system.
Practical Considerations
The sheath is available in various sizes to accommodate different procedural needs and vessel sizes. It is compatible with a range of catheters and stents, making it versatile for different endovascular applications. Clinicians should be familiar with the technique of inserting and manipulating the sheath to minimize complications.
Related Literature
The linked study compared leakage rates through different introducer sheaths used in fenestrated endovascular aortic aneurysm repair. It evaluated the performance of the Gore DrySeal Flex, Cook Performer Check-Flo, and Medtronic Sentrant sheaths. The study found variations in leakage rates, highlighting the importance of selecting the appropriate sheath for procedures involving multiple device insertions. However, the study was conducted in vitro, which may not fully replicate clinical conditions.
Frequently Asked Questions
What is the Gore Introducer Sheath with Silicone Pinch Valve used for?
It is used to facilitate the insertion of catheters and other devices into the vascular system during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in endovascular procedures where maintaining hemostasis is important, especially when multiple devices are inserted into the vascular system.
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.