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Trufill Dcs Orbit Detachable Coil and Trufill Dcs Syringe Also Known as the Trufill Dcs Orbit Detachable Coil System
Cordis Neurovascular
Summary: The Trufill DCS Orbit Detachable Coil System is a device used for endovascular occlusion of cerebral aneurysms. Key evidence highlights its use in maintaining aneurysmal occlusion stability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K030963 ↗
Decision Date ?
June 20, 2003
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
9 studies
The Trufill DCS Orbit Detachable Coil System was cleared by the FDA via the 510(k) pathway on June 20, 2003. It is manufactured by Cordis Neurovascular and is classified as a Class 2 device.
What It Is
The Trufill DCS Orbit 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.
FDA-Cleared Indications
- Endovascular occlusion of cerebral aneurysms.
- Embolization of cerebral aneurysms using detachable platinum coils.
Clinical Applications
- Endovascular coil embolization of selected intracranial, or cerebral, aneurysms.
- Treatment of cerebral aneurysms when occlusion is indicated to reduce blood flow into the aneurysm.
- Placement through a microcatheter during a neurointerventional embolization procedure.
Reported off-label uses
- Coil embolization of selected non-aneurysmal intracranial vascular lesions may be reported in clinical practice, but use depends on the specific device labeling, anatomy and physician judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes three studies, comprising retrospective and prospective analyses, with publication years ranging from 2008 to 2013. These studies provide insights into the device's performance and clinical outcomes.
Reported Outcomes
Published studies report that the Trufill DCS Orbit Detachable Coil System is effective in achieving and maintaining aneurysmal occlusion. The device has demonstrated stability in initial occlusion, contributing to positive midterm clinical outcomes.
Safety Profile
Reported complications include typical risks associated with endovascular procedures, such as coil migration and thromboembolic events. However, specific adverse event rates are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to evaluate long-term outcomes and potential complications in diverse patient populations.
Practical Considerations
- The system uses detachable platinum coils delivered through a compatible microcatheter; coil diameter, length and catheter compatibility must be selected for the aneurysm and vessel anatomy.
- The Trufill DCS syringe is part of the delivery system and is used to control the detachment process according to the manufacturer’s instructions.
- MRI safety depends on the exact coil configuration, implant conditions and current labeling. The treating team should verify MRI conditions before scanning.
- Important risks include thromboembolism, vessel injury, aneurysm rupture, hemorrhage, incomplete occlusion, recurrence and neurological complications.
- Contraindications, warnings and compatibility requirements should be checked in the current manufacturer’s instructions for use before treatment.
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 occlusion of cerebral aneurysms.
What outcomes have been reported in clinical studies?
Studies report effective aneurysmal occlusion and stability of initial occlusion over the midterm.
What complications have been reported?
Reported complications include coil migration and thromboembolic events, typical of 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.