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trufill dcs detachable coil and frufill dcs syringe also known as the trufill dcs detachable coil system
Cordis Neurovascular
Summary: The Trufill DCS Detachable Coil System is used for the embolization of cerebral aneurysms. It is FDA 510(k) cleared and supported by multiple studies indicating its efficacy in aneurysm occlusion.
FDA Clearance Information
Pathway 510K
Number K014041 ↗
Decision Date March 7, 2002
Product Code HCG
Device Class Class 2
Evidence 9 studies
The Trufill DCS Detachable Coil System was cleared via the FDA 510(k) pathway on March 7, 2002. Manufactured by Cordis Neurovascular, it is classified as a Class 2 device.
What It Is
The Trufill DCS Detachable Coil System is a medical device designed for the embolization of cerebral aneurysms. It utilizes detachable platinum coils to achieve endovascular occlusion, providing a minimally invasive treatment option.
Clinical Applications
Commonly used in the treatment of both ruptured and unruptured cerebral aneurysms, the Trufill DCS Detachable Coil System is employed in neuro-interventional procedures to prevent aneurysm rupture and subsequent hemorrhagic stroke.
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 performance.
Reported Outcomes
Published studies report that the Trufill DCS Detachable Coil System is effective in achieving stable aneurysm occlusion. The device has been shown to conform well to complex aneurysm shapes, facilitating successful embolization in a variety of clinical scenarios.
Safety Profile
Reported complications include challenges with catheterization in certain vascular anatomies, as noted in case studies. However, overall safety profiles from the studies indicate a low incidence of adverse events directly attributable to the device.
Evidence Limitations
The evidence base is limited by the small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to evaluate long-term outcomes and to compare the device's performance with newer technologies.
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 hemorrhagic stroke.
What outcomes have been reported in clinical studies?
Studies report effective aneurysm occlusion and stability in a variety of clinical scenarios, with good conformability to complex aneurysm shapes.
What complications have been reported?
Safety data indicate a low incidence of adverse events, with some challenges in catheterization noted in specific vascular anatomies.
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.