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trufill n-butyl cyanoacrylate n-bca liquid embolic system
Cerenovus
Summary: The Trufill n-Butyl Cyanoacrylate Liquid Embolic System is used for embolization procedures, particularly in treating cerebral arteriovenous malformations and subdural hematomas. Key evidence highlights its efficacy in reducing flow in AVMs and its potential use in middle meningeal artery embolization.
FDA Clearance Information
Pathway PMA
Number P990040 ↗
Decision Date November 5, 2014
Product Code KGG
Device Class Class 3
Evidence 9 studies
The Trufill n-Butyl Cyanoacrylate was cleared by the FDA via the PMA pathway on November 5, 2014. It is manufactured by Cerenovus and classified as a Class III device.
What It Is
The Trufill n-Butyl Cyanoacrylate Liquid Embolic System is a medical device used for embolization, a procedure that blocks blood vessels to prevent blood flow to certain areas. It is primarily used in neurovascular interventions to treat conditions like cerebral arteriovenous malformations.
Clinical Applications
Common clinical scenarios for the Trufill n-Butyl Cyanoacrylate include embolization of cerebral arteriovenous malformations and middle meningeal artery embolization for chronic subdural hematomas. It is also used in endoleak repairs and treating intracranial infectious aneurysms.
Evidence Summary
The available literature includes a range of study types such as RCTs, prospective, and retrospective studies, with a total of 8 studies reviewed. The studies span from 2014 to 2026, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the Trufill n-Butyl Cyanoacrylate is effective in reducing blood flow in cerebral arteriovenous malformations and is a viable option for middle meningeal artery embolization in chronic subdural hematomas. It has also been compared to other embolic agents for cost and efficacy in endoleak repairs.
Safety Profile
Reported complications include morbidity and mortality associated with its use in cerebral arteriovenous malformations. The safety profile varies depending on the clinical application and patient condition, with some studies noting increased risks in specific scenarios.
Evidence Limitations
Evidence gaps include limited data on long-term outcomes and comparative effectiveness with other embolic agents. Further research is needed to fully understand the safety profile and optimize clinical protocols for different indications.
Linked Studies (9)
PubMed • 2026
Middle Meningeal Artery Embolization with n-Butyl Cyanoacrylate for the Treatment of Subdural Hematomas: The MEMBRANE Study Design.
Stroke (Hoboken, N.J.)
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2021
Comparison of Cost and Efficacy of Trufill® vs Histoacryl® n-Butyl Cyanoacrylate for Translumbar Type 2 Endoleak Embolization.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2014
ONYX versus n-BCA for embolization of cranial dural arteriovenous fistulas.
Journal of neurointerventional surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2013
Complex shaped detachable platinum coil system for the treatment of cerebral aneurysms: the Codman Trufill DCS and Trufill DCS Orbit Detachable Coil System COMPLEX Registry final results.
Journal of neurointerventional surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2012
Initial Clinical Experience with a New Complex-Shaped Detachable Platinum Coil System for the Treatment of Intracranial Cerebral Aneurysms. The Cordis Trufill DCS Detachable Coil System.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source → PubMed • 2008
Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: Trufill DCS Orbit detachable coil system registry interim results.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2007
Combined use of TruFill DCS detachable coil system and Guglielmi detachable coil for embolization of meningioma fed by branches of the cavernous internal carotid artery.
Neurologia medico-chirurgica
View Source → PubMed • 2002
N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations: results of a prospective, randomized, multi-center trial.
AJNR. American journal of neuroradiology
RCT|prospective|retrospective|case Series|other View Source → ClinicalTrials.gov
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
View Source →Frequently Asked Questions
What are the clinical indications for Trufill n-Butyl Cyanoacrylate?
The device is indicated for embolization procedures in conditions such as cerebral arteriovenous malformations and chronic subdural hematomas.
What outcomes have been reported in clinical studies?
Studies have reported effective flow reduction in AVMs and potential use in middle meningeal artery embolization, with comparisons showing cost and efficacy benefits in endoleak repairs.
What complications have been reported?
Safety data indicate potential morbidity and mortality in AVM treatments, with risks varying by clinical scenario and patient condition.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.