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Trufill Dcs Orbit Detachable Coil and Trufill Dcs Syringe Also Known as Trufill Dcs Orbit Detachable Coil System
Cordis Neurovascular
Summary: The Trufill DCS Orbit Detachable Coil System is a device used for embolization in cerebral aneurysms. Key evidence includes studies on its efficacy and safety in maintaining aneurysmal occlusion.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K032553 ↗
Decision Date ?
September 23, 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 September 23, 2003. It is manufactured by Cordis Neurovascular and classified as a Class 2 device.
What It Is
The Trufill DCS Orbit Detachable Coil System is designed for the endovascular treatment of cerebral aneurysms. It functions by deploying detachable platinum coils to achieve embolization and occlusion of the aneurysm.
FDA-Cleared Indications
- Endovascular embolization of cerebral aneurysms.
- Occlusion of cerebral aneurysms when treatment with detachable embolization coils is indicated.
Clinical Applications
- Endovascular coil embolization of an intracranial cerebral aneurysm.
- Treatment of a cerebral aneurysm to reduce blood flow into the aneurysm sac.
- Planned endovascular management of a cerebral aneurysm when aneurysm occlusion is intended.
Evidence Summary
The available literature includes three studies, comprising various study types such as prospective and retrospective analyses. These studies span from 2008 to 2013, providing insights into the device's performance.
Reported Outcomes
Published studies report that the Trufill DCS Orbit Detachable Coil System is effective in achieving initial aneurysmal occlusion and maintaining stability over time. The device has been shown to perform well in both short-term and midterm evaluations.
Safety Profile
Reported complications include typical risks associated with endovascular procedures, such as coil migration and aneurysm perforation. However, the studies did not provide detailed safety data.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and detailed safety outcomes. Further research is needed to establish long-term efficacy and safety profiles.
Practical Considerations
- The system includes detachable platinum coils and a delivery system; coil dimensions and configuration must be selected for the aneurysm's size and shape.
- It is used through a compatible microcatheter positioned in the cerebral circulation under fluoroscopic or other approved imaging guidance.
- The detachable coil and delivery components must be compatible with the specified catheter and system instructions for use.
- MRI safety and scanning conditions should be confirmed in the current manufacturer labeling before MRI examination; do not assume that every configuration has identical MRI conditions.
- Important risks include thromboembolism, vessel injury, aneurysm rupture, coil migration or incomplete occlusion, and neurologic complications. Contraindications and warnings are defined by the current labeling.
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 embolization of cerebral aneurysms.
What outcomes have been reported in clinical studies?
Studies report effective aneurysmal occlusion and stability of occlusion over time.
What complications have been reported?
Reported complications include coil migration and aneurysm perforation, though detailed safety data is limited.
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.