Innerdyne Radially Expanding Vascular Access System Heparin Coated

FDA-Cleared Indications

• Vascular access for the introduction of catheters and other vascular instruments.
• Use in procedures requiring access to the vascular system, including catheter-based embolization procedures.

Clinical Applications

• Obtaining vascular access for catheter-based embolization procedures.
• Providing access for placement or manipulation of intravascular catheters and other instruments.
• Supporting minimally invasive vascular procedures in which a stable access route is needed.

Reported off-label uses

• Use as an access route for other endovascular interventions when selected by the treating clinician based on device compatibility and patient anatomy.

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 the device size and configuration to match the access vessel, patient anatomy, and instruments being used.
• Confirm compatibility with the guidewires, catheters, sheaths, and other equipment planned for the procedure.
• The heparin coating does not eliminate the risk of thrombosis, bleeding, infection, arterial injury, or other vascular-access complications.
• Use imaging guidance and appropriate sterile technique; follow the current manufacturer instructions for preparation, insertion, removal, and disposal.
• MRI safety information should be confirmed in the current device labeling. Do not assume the device is MR safe or MR conditional without that documentation.