Rotating Hemostatic Valve

FDA-Cleared Indications

• Used as an accessory with percutaneous catheters and intravascular instruments during vascular procedures.
• Intended to maintain hemostasis at the catheter or instrument entry point while permitting device passage and manipulation.

Clinical Applications

• Maintaining hemostasis during percutaneous vascular catheterization.
• Allowing passage, advancement, withdrawal, and exchange of guidewires and catheters.
• Facilitating catheter manipulation during endovascular diagnostic and therapeutic procedures.
• Providing access control during procedures involving venous or arterial catheter systems.

Reported off-label uses

• Use with specialized nonvascular access systems or instruments outside the device's labeled catheter applications may occur in practice, but should be determined by the treating clinician and applicable device instructions.

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

• Select a valve compatible with the catheter, guidewire, sheath, and other instruments being used; check the device's labeled inner diameter and compatibility information.
• Tighten the rotating seal enough to reduce blood leakage while avoiding excessive force that could restrict device movement or damage the catheter or guidewire.
• Flush the valve and connected system according to the procedure protocol to reduce air entry and clot formation.
• The record does not establish MRI safety. Review the current manufacturer labeling before using the valve in or near an MRI environment.
• Do not use a damaged, leaking, contaminated, or expired device. Contraindications and warnings should be taken from the current package insert and procedure-specific instructions.