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Trufill Dcs Orbit Detachable Coil System Line Extension
Cordis Neurovascular
Summary: The Trufill DCS Orbit Detachable Coil System, manufactured by Cordis Neurovascular, is 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 ?
K053197 ↗
Decision Date ?
December 15, 2005
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 December 15, 2005. It is manufactured by Cordis Neurovascular and classified as a Class 2 device.
What It Is
The Trufill DCS Orbit Detachable Coil System is a medical device designed for the endovascular treatment of cerebral aneurysms. It utilizes detachable platinum coils to achieve embolization and occlusion of aneurysms.
FDA-Cleared Indications
- Endovascular embolization and occlusion of cerebral aneurysms.
- Use as a neurovascular embolization device under fluoroscopic imaging guidance.
Clinical Applications
- Endovascular coil embolization of selected intracranial cerebral aneurysms.
- Placement of detachable platinum coils to reduce or stop blood flow into an aneurysm.
- Treatment of cerebral aneurysms when a catheter-based approach is selected instead of, or as an alternative to, open surgical clipping.
Evidence Summary
The available literature includes two studies published between 2008 and 2013. These studies encompass various methodologies, including registry data analysis, focusing on the device's performance and safety.
Reported Outcomes
Published studies report that the Trufill DCS Orbit Detachable Coil System is effective in achieving and maintaining aneurysmal occlusion. The studies highlight its utility in providing stable embolization over the midterm period.
Safety Profile
Reported complications include typical risks associated with endovascular procedures, although specific adverse events were not detailed in the provided studies. Overall, the device is considered safe within the studied contexts.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to establish long-term efficacy and safety, as well as to explore outcomes in diverse patient populations.
Practical Considerations
- The system includes detachable platinum coils and a delivery catheter; coil diameter and length must be selected according to the aneurysm and parent-vessel anatomy.
- Placement requires vascular access, catheter navigation, and fluoroscopic or other X-ray imaging by a trained neurointerventional team.
- The device should be used only with compatible delivery components and according to the current manufacturer instructions for use.
- MRI eligibility depends on the specific device configuration and current labeling; confirm MR conditions before scanning.
- Important risks include thromboembolism, vessel perforation, aneurysm rupture, ischemic or hemorrhagic stroke, coil migration, incomplete occlusion, and recurrence. Patient-specific contraindications and anticoagulation or antiplatelet requirements must be assessed 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 embolization of cerebral aneurysms, particularly in cases where endovascular treatment is appropriate.
What outcomes have been reported in clinical studies?
Studies report effective aneurysmal occlusion and stability of embolization over the midterm period.
What complications have been reported?
Reported complications include general risks associated with endovascular procedures, though specific adverse events were not detailed in the 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.