Embolic beads
Gel-Bead Embolization Spheres
A bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.
Gel-Bead Embolization Spheres models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 3800 | — | Not stated | Available |
| 3801 | — | Not stated | Available |
| 3802 | — | Not stated | Available |
| 3803 | — | Not stated | Available |
| 3820 | — | Not stated | Available |
| 3821 | — | Not stated | Available |
| 3822 | — | Not stated | Available |
| 3823 | — | Not stated | Available |
| 3824 | — | Not stated | Available |
| 3825 | — | Not stated | Available |
Procedures that use embolic beads
Frequently asked questions
What is Gel-Bead Embolization Spheres used for?
A bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.
Who makes Gel-Bead Embolization Spheres?
Gel-Bead Embolization Spheres is made by Vascular Solutions, Inc.. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does Gel-Bead Embolization Spheres come in?
The FDA device database does not list sizes for Gel-Bead Embolization Spheres. Check the instructions for use or ask a Vascular Solutions, Inc. representative.
Is Gel-Bead Embolization Spheres MRI safe?
The FDA device database entry for Gel-Bead Embolization Spheres does not state its MRI safety status. Check the labeling before MRI.
Is Gel-Bead Embolization Spheres FDA cleared?
Gel-Bead Embolization Spheres is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Vascular Solutions, Inc. sales representative?
Vascular Solutions, Inc. has not listed representatives on LA Vascular yet. Visit the Vascular Solutions, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.