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Gore Introducer Sheath with Silicone Pinch Valve
Summary: The Gore Introducer Sheath with Silicone Pinch Valve is a medical device used to facilitate the insertion of catheters and other devices into blood vessels. It is primarily used by interventional radiologists and vascular surgeons during procedures like embolization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082356 ↗
Decision Date ?
August 28, 2008
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Gore Introducer Sheath with Silicone Pinch Valve was cleared through the FDA 510k pathway on August 28, 2008. Manufactured by W.L. Gore & Associates, it 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 medical device designed to provide vascular access for the insertion of catheters and other medical instruments. The silicone pinch valve minimizes blood leakage during procedures, enhancing procedural safety and efficiency. This device is particularly useful in complex interventions where multiple devices need to be introduced into the vascular system.
FDA-Cleared Indications
- Facilitation of the percutaneous insertion of catheters and other devices into the vascular system.
- Use as an introducer sheath during procedures that require intravascular access.
Clinical Applications
- Providing vascular access for catheter-based embolization procedures.
- Providing vascular access for endovascular aneurysm and pseudoaneurysm treatment.
- Introducing and exchanging guidewires, catheters, and other compatible intravascular devices.
- Maintaining access to a blood vessel during diagnostic or therapeutic endovascular procedures.
Practical Considerations
- Available size and length options should be selected according to the target vessel, access route, catheter diameter, and planned procedure.
- The sheath is commonly placed through percutaneous femoral, radial, brachial, or other vascular access, depending on the intervention.
- Confirm compatibility with the guidewire, catheter, embolic device, and other equipment before use.
- The silicone pinch valve is intended to reduce blood leakage during device insertion and exchange, but it does not eliminate bleeding risk.
- MRI safety depends on the specific device configuration and labeling; verify the current product instructions before MRI exposure. The sheath is a temporary-use device and is removed at the end of the procedure unless the labeling states otherwise.
Related Literature
The linked study compared leakage rates of various large bore sheaths used in fenestrated endovascular aneurysm repair (fEVAR). It assessed the performance of the Gore DrySeal Flex, Cook Performer Check-Flo, and Medtronic Sentrant in an in vitro setting. The study found that all sheaths experienced some degree of blood leakage when multiple smaller sheaths were inserted, highlighting the need for improved valve designs. However, the study's in vitro nature may limit its applicability to clinical practice.
Procedures that use this device
Frequently Asked Questions
What is Gore Introducer Sheath with Silicone Pinch Valve used for?
It is used to facilitate the insertion of catheters and other medical devices into blood vessels during procedures like embolization and aneurysm repair.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings, particularly during complex vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating vascular access for the insertion of catheters and other devices during procedures such as embolization and aneurysm repair.
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.