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trufill dcs orbit detachable coil system
Codman & Shurtleff
Summary: The Trufill DCS Orbit Detachable Coil System is a medical device used for the endovascular occlusion of cerebral aneurysms. It is designed to provide stability in aneurysmal occlusion. Key evidence includes studies on its performance and safety.
FDA Clearance Information
Pathway 510K
Number K093973 ↗
Decision Date May 26, 2010
Product Code HCG
Device Class Class 2
Evidence 9 studies
The Trufill DCS Orbit Detachable Coil System was cleared by the FDA through the 510(k) pathway on May 26, 2010. It is manufactured by Codman & Shurtleff and classified as a Class 2 device under product code HCG.
What It Is
The Trufill DCS Orbit Detachable Coil System is a detachable platinum coil system used in the endovascular treatment of cerebral aneurysms. It is designed to occlude aneurysms by promoting thrombosis within the aneurysmal sac.
Clinical Applications
This device is commonly used in the treatment of cerebral aneurysms, particularly in cases where endovascular intervention is preferred over surgical clipping. It is suitable for complex aneurysm shapes due to its detachable coil design.
Evidence Summary
The available literature includes three studies: two from PubMed and one from ClinicalTrials.gov. These studies range from 2008 to 2013 and include registry data and clinical experience reports. Study types include prospective and retrospective analyses.
Reported Outcomes
Published studies report that the Trufill DCS Orbit Detachable Coil System is effective in achieving stable aneurysmal occlusion. The device has been shown to maintain occlusion over midterm follow-up periods, with positive outcomes in complex aneurysm cases.
Safety Profile
Reported complications include device-related adverse events, though specific details are not extensively documented in the provided studies. Overall, the device is considered safe with a manageable risk profile.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials. Most data come from registry analyses and retrospective studies, which may introduce bias. Further research is needed to confirm long-term safety and efficacy.
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 Orbit Detachable Coil System?
The device is indicated for the endovascular treatment of cerebral aneurysms, particularly in cases where complex aneurysm shapes are present.
What outcomes have been reported in clinical studies?
Studies report effective aneurysmal occlusion and stability over midterm follow-up periods, with positive outcomes in complex cases.
What complications have been reported?
Reported complications include device-related adverse events, though specific details are limited in the available studies.
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.