Modification to Ivs Introducer Set Model 1003

FDA-Cleared Indications

• Introduction of embolization coils into the vascular system during endovascular procedures

Clinical Applications

• Providing vascular access for procedures in which embolization coils are delivered to a target vessel
• Supporting coil embolization of abnormal or unwanted blood flow when performed according to the device labeling
• Introducing embolization equipment through a percutaneous vascular access site in an interventional procedure

Reported off-label uses

• Use of an introducer of this type for delivery of other compatible embolic materials or endovascular devices may occur in clinical practice, but this is not established by the supplied FDA indication and should follow institutional policy and the device labeling.

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

• Confirm that the sheath, dilator, and any accessory components are compatible with the selected embolization coil system and catheter.
• Select the appropriate size and length for the access vessel, delivery system, and planned target anatomy.
• Use sterile technique and fluoroscopic or other appropriate imaging guidance to reduce the risk of vascular injury, bleeding, infection, or malposition.
• Review the manufacturer’s labeling for contraindications, warnings, and MRI conditions; MRI safety cannot be determined from the supplied FDA record alone.
• This is generally a single-use vascular access device. It should not be reused or reprocessed unless the labeling specifically permits it.