Microcruiser Plus Introducer Set

FDA-Cleared Indications

• Used to introduce and deliver embolization coils into the vascular system.
• Used during procedures intended to occlude selected blood vessels or vascular abnormalities with embolization coils.

Clinical Applications

• Delivery of embolization coils for treatment of cerebral aneurysms.
• Delivery of embolization coils for embolization of arteriovenous malformations.
• Catheter-based occlusion of selected abnormal or bleeding vessels when embolization coils are indicated.

Reported off-label uses

• Coil embolization of selected visceral, pelvic, renal, splenic, or other peripheral vascular lesions may be performed with this device category when clinically appropriate, subject to the specific product labeling and institutional protocols.

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 set may include an introducer sheath and dilator; size selection should match the intended catheter, guidewire, access site, and vessel anatomy.
• Compatibility with the embolization coil delivery system and other interventional equipment must be confirmed before use.
• Use requires fluoroscopic or other appropriate image guidance and clinicians trained in vascular access, catheter manipulation, and embolization techniques.
• The FDA record provided does not establish MRI safety; MRI conditions should be confirmed from the current manufacturer labeling before scanning a patient with the device in place.
• Contraindications, warnings, vascular-access risks, bleeding risk, infection risk, vessel injury, and non-target embolization should be assessed using the current instructions for use and the patient's clinical condition.