Trufill N-Butyl Cyanoacrylate N-Bca Liquid Embolic System

FDA-Cleared Indications

• The FDA record describes approval to replace the existing sterile pouch for the TruFill n-BCA Liquid Embolic System.
• The approved packaging change includes a new pouch coating and new thumb notches.
• The replacement pouch uses the same materials as the existing pouch and is sourced from a new vendor, Oliver-Tolas Healthcare Products.
• The FDA record also identifies tantalum powder components as part of the approved packaging change.

Clinical Applications

• Use of the TruFill system for embolization procedures when consistent with the complete FDA-approved product labeling.
• Delivery of n-BCA liquid embolic material through a catheter to occlude selected blood vessels.
• Use with tantalum powder to provide radiographic visibility during embolization.

Reported off-label uses

• Embolization of cerebral arteriovenous malformations has been reported in clinical practice and literature, but the specific indication should be confirmed against the current product labeling.
• Middle meningeal artery embolization for chronic subdural hematoma has been reported with n-BCA and other embolic agents, but may be off-label depending on the labeling and clinical circumstances.
• Embolization of selected intracranial infectious aneurysms has been described in clinical practice, but should not be assumed to be an on-label indication.
• Treatment of selected endoleaks has been reported with liquid embolic agents, but use in this setting may be off-label and requires case-specific assessment.

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

• n-BCA polymerizes on contact with ionic solutions such as blood or saline. Preparation, concentration, injection speed and catheter technique affect polymerization time and embolic penetration.
• The system is used through a compatible microcatheter under fluoroscopic or angiographic guidance. Catheter compatibility and the manufacturer's instructions for preparation and delivery must be verified before use.
• Tantalum powder is used to improve fluoroscopic visualization. The embolic material is permanent, so reflux, non-target embolization and unintended vessel occlusion are important risks.
• MRI considerations depend on the complete system labeling and the implanted embolic material. The current FDA record supplied does not provide an MRI safety classification; consult the current instructions for use.
• Potential contraindications and precautions include allergy or sensitivity to product components, inability to safely catheterize the target vessel, uncontrolled bleeding or infection at the access site, and high risk of embolization to critical non-target vessels.