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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 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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an introducer sheath to provide access for the insertion of catheters and other intravascular devices during endovascular procedures.
- Use when temporary vascular access and hemostatic control are needed during catheter-based intervention.
Clinical Applications
- Providing vascular access for endovascular catheter and device procedures.
- Maintaining a conduit for repeated insertion, exchange, and removal of intravascular instruments.
- Helping limit blood leakage at the sheath valve during vascular interventions.
- Supporting complex endovascular procedures that require multiple catheters or devices.
Reported off-label uses
- Use during embolization procedures, including uterine artery, prostate artery, visceral artery, and gastrointestinal bleeding embolization, when the sheath size and anatomy are appropriate.
- Use during neurointerventional procedures such as aneurysm coiling or AVM embolization when selected by the treating physician for vascular access.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Available sizes and lengths should be selected according to the access vessel, planned devices, and procedural anatomy.
- Device compatibility depends on the sheath inner diameter, catheter or device profile, guidewire requirements, and valve design.
- Insertion and manipulation should be performed with appropriate imaging guidance and sterile technique to reduce bleeding, vascular injury, thrombosis, infection, and air entry.
- The silicone pinch valve is intended to help with hemostasis but does not eliminate the risk of bleeding; anticoagulation, vessel size, and access-site management remain important.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling for the specific model and configuration before MRI exposure.
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.
Procedures that use this device
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.