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trufill pva particles
Cordis Neurovascular
Summary: Trufill PVA Particles are embolic agents used to occlude blood vessels in various therapeutic procedures. They are primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway 510K
Number K965174 ↗
Decision Date March 21, 1997
Product Code HCG
Device Class Class 2
Evidence 9 studies
The Trufill PVA Particles were cleared via the FDA 510k pathway on March 21, 1997. Manufactured by Cordis Neurovascular, this Class 2 device is intended for embolization procedures.
What It Is
Trufill PVA Particles are polyvinyl alcohol particles used as embolic agents to occlude blood vessels. They are designed to be injected into the vasculature to block blood flow to specific areas, often to treat arteriovenous malformations or hypervascular tumors. The particles come in various sizes to accommodate different vessel diameters and ensure precise embolization.
Clinical Applications
Trufill PVA Particles are commonly used in interventional radiology and neurosurgery for procedures requiring vessel embolization. They are particularly useful in treating conditions such as arteriovenous malformations, uterine fibroids, and certain types of tumors. These procedures are typically performed in hospital settings, often in specialized radiology or surgical suites.
Indications for Use
The FDA indications for Trufill PVA Particles include embolization of hypervascular tumors and arteriovenous malformations. This means they are used to block blood flow to these abnormal or excessive blood vessel formations, reducing symptoms or preparing for further treatment.
Practical Considerations
Trufill PVA Particles are available in various sizes, allowing for customization based on the target vessel size. They are compatible with standard embolization catheters. Clinicians should be familiar with the injection technique to ensure effective embolization and minimize complications.
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 PVA Particles used for?
Trufill PVA Particles are used to occlude blood vessels in procedures treating arteriovenous malformations and hypervascular tumors.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use Trufill PVA Particles.
What are the FDA-cleared indications?
The FDA-cleared indications include embolization of hypervascular tumors and arteriovenous 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.