Embolic beads
Embozene Microspheres (Opaque)
A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.
Embozene Microspheres (Opaque) 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 |
|---|---|---|---|
| 10410-S0 | Outer Diameter 40 µm | Not stated | Available |
| 10420-S0 | Outer Diameter 40 µm | Not stated | Available |
| 10710-S0 | Outer Diameter 75 µm | Not stated | Available |
| 10720-S0 | Outer Diameter 75 µm | Not stated | Available |
| 11010-S0 | Outer Diameter 100 µm | Not stated | Available |
| 11020-S0 | Outer Diameter 100 µm | Not stated | Available |
| 12010-S0 | Outer Diameter 250 µm | Not stated | Available |
| 12020-S0 | Outer Diameter 250 µm | Not stated | Available |
| 14010-S0 | Outer Diameter 400 µm | Not stated | Available |
| 14020-S0 | Outer Diameter 400 µm | Not stated | Available |
| 15010-S0 | Outer Diameter 500 µm | Not stated | Available |
| 15020-S0 | Outer Diameter 500 µm | Not stated | Available |
| 17010-S0 | Outer Diameter 700 µm | Not stated | Available |
| 17020-S0 | Outer Diameter 700 µm | Not stated | Available |
| 19010-S0 | Outer Diameter 900 µm | Not stated | Available |
| 19020-S0 | Outer Diameter 900 µm | Not stated | Available |
| 111010-S0 | Outer Diameter 1100 µm | Not stated | Available |
| 111020-S0 | Outer Diameter 1100 µm | Not stated | Available |
| 113010-S0 | Outer Diameter 1300 µm | Not stated | Available |
| 113020-S0 | Outer Diameter 1300 µm | Not stated | Available |
Procedures that use embolic beads
Frequently asked questions
What is Embozene Microspheres (Opaque) used for?
A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.
Who makes Embozene Microspheres (Opaque)?
Embozene Microspheres (Opaque) is made by CeloNova Biosciences, Inc.. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does Embozene Microspheres (Opaque) come in?
Sizes listed for Embozene Microspheres (Opaque): Outer Diameter: 40–1,300 µm. Confirm availability with the manufacturer's instructions for use.
Is Embozene Microspheres (Opaque) MRI safe?
The FDA device database entry for Embozene Microspheres (Opaque) does not state its MRI safety status. Check the labeling before MRI.
Is Embozene Microspheres (Opaque) FDA cleared?
Embozene Microspheres (Opaque) is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a CeloNova Biosciences, Inc. sales representative?
CeloNova Biosciences, Inc. has not listed representatives on LA Vascular yet. Visit the CeloNova Biosciences, 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.