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gelspheres beadblock compressible microspheres
Biocompatibles Uk
Summary: Gelspheres Beadblock Compressible Microspheres are used for embolization procedures to occlude blood vessels. They are typically used by interventional radiologists in various therapeutic settings.
FDA Clearance Information
Pathway
510K
Number
K033761 ↗
Decision Date
February 4, 2004
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 4, 2004. Manufactured by Biocompatibles UK, it is classified as a Class 2 medical device.
What It Is
Gelspheres Beadblock Compressible Microspheres are small, spherical particles designed for embolization, a procedure to block blood flow to certain areas. These microspheres are compressible, allowing them to navigate through the vascular system and lodge in target vessels to occlude them effectively. This device is particularly useful in procedures requiring precise embolization, such as in the treatment of hypervascular tumors or arteriovenous malformations.
Clinical Applications
These microspheres are commonly used in interventional radiology, particularly for embolization procedures in oncology to treat tumors by cutting off their blood supply. They are also used in gynecology for uterine fibroid embolization and in other specialties where vascular occlusion is required. The device is suitable for use in hospital settings, particularly in catheterization labs or interventional suites.
Indications for Use
The FDA-cleared indications for this device include embolization of hypervascular tumors and arteriovenous malformations. It is intended for patients who require targeted vessel occlusion to manage or treat specific medical conditions.
Practical Considerations
The microspheres come in various sizes to accommodate different vessel diameters and are compatible with standard microcatheters. Proper technique involves selecting the appropriate size and ensuring precise delivery to the target site to achieve effective embolization.
Frequently Asked Questions
What is Gelspheres Beadblock Microspheres used for?
They are used for embolization procedures to occlude blood vessels, often in the treatment of tumors or arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device, especially in oncology and gynecology for procedures like tumor embolization and uterine fibroid embolization.
What are the FDA-cleared indications?
The device is indicated for the embolization of hypervascular tumors and arteriovenous malformations, providing targeted vessel occlusion.
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.