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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 ?
510(k)
Number ?
K082324 ↗
Decision Date ?
September 12, 2008
Product Code ?
HCG Device, Neurovascular Embolization
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.
FDA-Cleared Indications
- Delivery of liquid embolic agents during neurovascular embolization procedures.
- Embolization of selected blood vessels to reduce or stop blood flow.
- Use in the treatment of neurovascular abnormalities when embolization is indicated.
Clinical Applications
- Controlled delivery of liquid embolic agents through a neurovascular catheter.
- Embolization of targeted cerebral or other neurovascular vessels.
- Treatment of selected vascular abnormalities requiring endovascular occlusion.
- Use during image-guided neurointerventional procedures performed in a hospital or specialized procedural setting.
Practical Considerations
- The syringe is used with compatible liquid embolic agents and catheter systems; clinicians should confirm compatibility before use.
- Precise handling is important because liquid embolic agents can polymerize or solidify, depending on the agent and delivery technique.
- Use requires training in neurovascular catheterization and embolization techniques.
- The syringe itself is not an implant and does not remain in the body after the procedure.
- MRI safety depends primarily on the embolic agent, catheter, and any other implanted or retained device used during the procedure; the syringe should not be brought into the MRI environment unless its labeling permits it.
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.