Embolic beads
Easi-Vue embolic microspheres System
by ABK Biomedical Incorporated
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.
Easi-Vue embolic microspheres System 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 |
|---|---|---|---|
| Administration Kit 50 micron | Particle Size 50 µm | MR Safe | Available |
| Administration Kit 100 micron | Particle Size 100 µm | MR Safe | Available |
| Administration Kit 150 micron | Particle Size 150 µm | MR Safe | Available |
| EVD50 | — | MR Safe | Available |
| EVD100 | — | MR Safe | Available |
| EVD150 | — | MR Safe | Available |
| Refill Syringe 50 micron | Particle Size 50 µm | MR Safe | Available |
| Refill Syringe 100 micron | Particle Size 100 µm | MR Safe | Available |
| Refill Syringe 150 micron | Particle Size 150 µm | MR Safe | Available |
FDA clearances
- 510(k) K234123 February 2024
- 510(k) K220567 September 2022
Procedures that use embolic beads
Frequently asked questions
What is Easi-Vue embolic microspheres System 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 Easi-Vue embolic microspheres System?
Easi-Vue embolic microspheres System is made by ABK Biomedical Incorporated. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does Easi-Vue embolic microspheres System come in?
Sizes listed for Easi-Vue embolic microspheres System: Particle Size: 50–150 µm. Confirm availability with the manufacturer's instructions for use.
Is Easi-Vue embolic microspheres System MRI safe?
The FDA device database lists Easi-Vue embolic microspheres System as MR Safe. Always follow the specific MRI conditions in the labeling.
Is Easi-Vue embolic microspheres System FDA cleared?
Easi-Vue embolic microspheres System is covered by FDA submissions K234123, K220567.
How do I contact a ABK Biomedical Incorporated sales representative?
ABK Biomedical Incorporated has not listed representatives on LA Vascular yet. Visit the ABK Biomedical Incorporated 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.