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the trufill dcs detachable coil system the trufill dcs orbit detachable coil system
Cordis Neurovascular
Summary: The Trufill DCS Detachable Coil System is used for embolization in cerebral aneurysms. It is FDA 510(k) cleared and supported by multiple studies. Key findings include its efficacy in aneurysm occlusion.
FDA Clearance Information
Pathway 510K
Number K063254 ↗
Decision Date December 7, 2006
Product Code HCG
Device Class Class 2
Evidence 9 studies
The Trufill DCS Detachable Coil System was cleared by the FDA through the 510(k) pathway on December 7, 2006. It is manufactured by Cordis Neurovascular and classified as a Class 2 device.
What It Is
The Trufill DCS Detachable Coil System is a medical device designed for endovascular embolization of cerebral aneurysms. It consists of complex-shaped platinum coils that are deployed to occlude aneurysms, reducing the risk of rupture.
Clinical Applications
This device is commonly used in the treatment of both ruptured and unruptured cerebral aneurysms. It is particularly useful in scenarios where minimally invasive endovascular techniques are preferred over surgical options.
Evidence Summary
The available literature includes five studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2007 to 2013, providing a comprehensive overview of the device's clinical application.
Reported Outcomes
Published studies report that the Trufill DCS Detachable Coil System is effective in achieving aneurysm occlusion. The device has been shown to maintain stability of occlusion over midterm follow-up periods, contributing to its efficacy in preventing aneurysm rupture.
Safety Profile
Reported complications include challenges in catheterization due to the size of the microcatheter, which may limit access to certain vascular territories. However, overall safety profiles in the studies reviewed indicate a favorable risk-benefit ratio.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and the variability in study designs. Further research is needed to assess long-term outcomes and to compare the device's performance with other embolization systems.
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 DCS Detachable Coil System?
The device is indicated for the embolization of cerebral aneurysms, both ruptured and unruptured, to prevent rupture and subsequent hemorrhagic events.
What outcomes have been reported in clinical studies?
Studies have reported effective aneurysm occlusion and stability of occlusion over midterm follow-up periods, indicating the device's efficacy in clinical use.
What complications have been reported?
Safety data from studies indicate complications related to catheterization challenges, but overall, the device has a favorable safety profile.
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.