Hqs Introducer

FDA-Cleared Indications

• Facilitation of the introduction and placement of embolization coils into blood vessels.
• Use as an introducer system during procedures in which embolization coils are delivered through a vascular access route.

Clinical Applications

• Providing a vascular conduit for delivery of embolization coils.
• Supporting coil embolization procedures to occlude a targeted blood vessel.
• Facilitating endovascular treatment of aneurysms or other vascular lesions when embolization coils are indicated.
• Facilitating coil embolization to control bleeding when the treating physician determines that coil delivery is appropriate.

Reported off-label uses

• Use as an access sheath for delivery of other compatible endovascular devices may occur in practice, but this is not established by the stated FDA indication for embolization-coil introduction.

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

• The appropriate sheath and dilator size depends on the access vessel, target anatomy, catheter system, and embolization coil system being used.
• The device should be used with compatible coils and delivery catheters according to the device labeling and the coil manufacturer's instructions.
• Placement is performed with sterile technique and imaging guidance, commonly fluoroscopy, to reduce the risk of vessel injury, bleeding, dissection, or malposition.
• MRI safety information is device- and configuration-specific; the current manufacturer labeling should be reviewed before MRI, particularly if any metallic component remains in the patient.
• Potential access-related complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and contrast-related reactions. The device is generally intended for single procedural use rather than long-term implantation.