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trufill dcs orbit detachable coil and trufill dcs syringe or trufill dcs syringe ii also known as the trufill dcs orbit
Cordis Neurovascular
Summary: The Trufill DCS Orbit Detachable Coil is a device used for embolization in cerebral aneurysms. It is FDA 510(k) cleared and supported by studies highlighting its efficacy in aneurysmal occlusion.
FDA Clearance Information
Pathway 510K
Number K080967 ↗
Decision Date May 2, 2008
Product Code HCG
Device Class Class 2
Evidence 9 studies
The Trufill DCS Orbit Detachable Coil, manufactured by Cordis Neurovascular, received FDA clearance via the 510(k) pathway on May 2, 2008. It is classified as a Class 2 device.
What It Is
The Trufill DCS Orbit Detachable Coil is a platinum coil system designed for the endovascular treatment of cerebral aneurysms. It is used to achieve embolization by occluding the aneurysm, thereby preventing rupture.
Clinical Applications
This device is commonly used in the treatment of cerebral aneurysms, particularly in cases where endovascular intervention is preferred over surgical methods. It is utilized in both elective and emergency settings for aneurysm management.
Evidence Summary
The available literature includes three studies, comprising randomized controlled trials and registry data, with publication years ranging from 2008 to 2013. These studies provide insights into the device's performance and safety profile.
Reported Outcomes
Published studies report that the Trufill DCS Orbit Detachable Coil is effective in achieving stable aneurysmal occlusion. The device has demonstrated favorable outcomes in maintaining occlusion over midterm follow-up periods.
Safety Profile
Reported complications include typical risks associated with endovascular procedures, such as thromboembolic events and coil migration. However, the studies did not highlight any unexpected safety concerns specific to this device.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and the lack of long-term follow-up data. Further research is needed to evaluate the long-term durability of aneurysm occlusion and to compare outcomes with other embolization devices.
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?
The device is indicated for the embolization of cerebral aneurysms, providing an endovascular option for aneurysm occlusion.
What outcomes have been reported in clinical studies?
Studies have reported effective aneurysmal occlusion and stability of occlusion over midterm follow-up periods.
What complications have been reported?
Safety data indicate risks of thromboembolic events and coil migration, consistent with endovascular procedures.
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.