đź“‹ FDA Reference
vascular occlusion system trufill pushable coils and trupush coil pusher
Cordis Neurovascular
Summary: The Trufill Pushable Coils are used for vascular embolization, primarily by interventional radiologists and neurosurgeons to occlude blood vessels. They are crucial in treating aneurysms and other vascular abnormalities.
FDA Clearance Information
Pathway 510K
Number K071962 ↗
Decision Date September 26, 2007
Product Code HCG
Device Class Class 2
Evidence 9 studies
The Trufill Pushable Coils received FDA clearance through the 510(k) pathway on September 26, 2007. Manufactured by Cordis Neurovascular, this device is classified as Class 2 under product code HCG.
What It Is
The Trufill Pushable Coils are medical devices used for embolization, a process that involves the intentional occlusion of blood vessels. These coils are deployed into blood vessels to prevent blood flow to a particular area, which is useful in treating aneurysms or vascular malformations. The coils are delivered via a catheter and are designed to be pushable, allowing for precise placement within the vasculature.
Clinical Applications
Trufill Pushable Coils are commonly used in interventional radiology and neurosurgery. They are particularly useful in the treatment of cerebral aneurysms, where they help prevent rupture by occluding the aneurysm sac. These coils are also used in peripheral vascular embolization procedures to manage arteriovenous malformations or to control bleeding in emergency settings. The device is typically used in hospital settings, particularly in catheterization labs or operating rooms.
Indications for Use
The FDA indications for the Trufill Pushable Coils include the embolization of blood vessels to treat aneurysms and other vascular abnormalities. This means they are used in patients who have conditions that require the blockage of blood flow to prevent complications like bleeding or rupture.
Practical Considerations
When using the Trufill Pushable Coils, clinicians should consider the size and shape of the target vessel to select the appropriate coil size. Compatibility with the catheter system is essential for successful deployment. Proper technique in coil placement is crucial to ensure effective occlusion and to minimize the risk of coil migration.
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 Pushable Coils used for?
Trufill Pushable Coils are used for vascular embolization to occlude blood vessels in the treatment of aneurysms and other vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device in procedures involving vascular embolization.
What are the FDA-cleared indications?
The FDA-cleared indications include embolization of blood vessels to treat aneurysms and other vascular abnormalities.
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.