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vascular occlusion system trufill pushable coils and trufill dcs orbit detachable coil sysem
Codman & Shurtleff
Summary: The TruFill Pushable Coils and TruFill DCS Orbit Detachable Coil System are used for vascular occlusion in embolization procedures. They are typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway 510K
Number K123560 ↗
Decision Date January 25, 2013
Product Code HCG
Device Class Class 2
Evidence 9 studies
The TruFill Coils were cleared through the FDA 510(k) pathway on January 25, 2013, by Codman & Shurtleff. They are classified as Class 2 medical devices.
What It Is
The TruFill Pushable Coils and TruFill DCS Orbit Detachable Coil System are medical devices designed for vascular occlusion. These coils are used to block blood flow in targeted blood vessels, aiding in the treatment of aneurysms or other vascular abnormalities. The pushable coils are manually advanced into the vessel, while the detachable system allows for precise placement and release of the coil.
Clinical Applications
These devices are commonly used in endovascular procedures to treat cerebral aneurysms and other vascular malformations. Interventional radiologists and neurosurgeons often employ these coils in hospital settings, particularly in the neurointerventional suite. The devices are suitable for adult and pediatric patients requiring embolization to prevent hemorrhage or to reduce blood flow to a specific area.
Indications for Use
The FDA indications for the TruFill Coils involve their use in embolization procedures to occlude blood vessels. This is particularly relevant for patients with aneurysms or vascular malformations that require reduced blood flow for treatment.
Practical Considerations
The TruFill Coils come in various sizes to accommodate different vessel diameters and anatomical locations. They are compatible with standard microcatheters used in embolization procedures. Clinicians should be familiar with the technique of coil deployment and ensure proper coil sizing for effective occlusion.
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 is TruFill Coils used for?
TruFill Coils are used for vascular occlusion in embolization procedures, particularly to treat aneurysms and vascular malformations.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use these devices in endovascular procedures.
What are the FDA-cleared indications?
The devices are indicated for use in embolization procedures to occlude blood vessels, particularly in the treatment of aneurysms and vascular malformations.
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.