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trufill dcs syringe
Cordis Neurovascular
Summary: The Trufill DCS Syringe is a medical device used for embolization procedures, primarily in neurovascular interventions. It is commonly used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway 510K
Number K082324 ↗
Decision Date September 12, 2008
Product Code HCG
Device Class Class 2
Evidence 9 studies
The Trufill DCS Syringe was cleared through the FDA 510(k) pathway on September 12, 2008. It is manufactured by Cordis Neurovascular and classified as a Class 2 device.
What It Is
The Trufill DCS Syringe is designed for use in embolization procedures, where it aids in the delivery of liquid embolic agents to occlude blood vessels. This device is crucial in treating arteriovenous malformations and other vascular abnormalities. Its design allows for precise control and delivery of embolic materials, which is essential in delicate neurovascular procedures.
Clinical Applications
The Trufill DCS Syringe is commonly used in neurointerventional procedures to treat conditions such as cerebral aneurysms and arteriovenous malformations. It is typically utilized in hospital settings, particularly in interventional radiology and neurosurgery departments. The device is suitable for adult patients requiring embolization therapy to prevent or manage hemorrhagic events.
Indications for Use
The FDA indications for the Trufill DCS Syringe involve its use in delivering embolic agents to block blood flow in targeted vessels. This is particularly useful in treating vascular abnormalities and preventing bleeding in the brain.
Practical Considerations
The Trufill DCS Syringe is available in various sizes to accommodate different procedural needs. It is compatible with standard embolic agents and catheters used in neurointerventional procedures. Clinicians should be trained in embolization techniques to ensure optimal outcomes.
Related Literature
The COMPLEX Post Market Surveillance Electronic Registry study aimed to gather post-market data on the use of the Trufill DCS Syringe. While specific findings are not detailed, such studies typically assess device performance and safety in real-world settings. Limitations may include the lack of a control group and potential biases inherent in registry data.
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 the Trufill DCS Syringe used for?
The Trufill DCS Syringe is used for delivering liquid embolic agents during embolization procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in neurovascular procedures.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolic agents to block blood flow in targeted vessels, particularly in neurovascular applications.
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.