Nanostim Introducer Kit

FDA-Cleared Indications

• Introduction of embolization coils into the vascular system during endovascular procedures.
• Use by trained clinicians when vascular access and controlled delivery of embolization coils are required.

Clinical Applications

• Introducing embolization coils for targeted occlusion of selected blood vessels.
• Supporting catheter-based treatment of vascular lesions in which embolization coils are indicated.
• Providing vascular access for procedures intended to control bleeding or reduce blood flow, when used with compatible embolization coils and other indicated devices.

Reported off-label uses

• Use in selected embolization procedures with devices or applications outside the specific cleared labeling may occur in clinical practice, but this should be determined by the treating specialist and is not an FDA-cleared indication for this kit.

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, catheter system, coil-delivery system and patient anatomy.
• The kit should be used with compatible catheters and embolization coils according to the device labeling and institutional procedure protocols.
• Placement is performed using standard vascular-access technique and imaging guidance, commonly fluoroscopy and angiography.
• The kit is not itself an implant; it is removed after vascular access and device delivery. The long-term duration therefore applies to the embolization coil or other implanted treatment device, not the introducer kit.
• MRI safety information should be confirmed in the current manufacturer labeling for the specific kit and any retained devices. The kit should not be assumed to be MRI safe while it is in place.