Embolic beads
Polyvinyl Alcohol Embolic Microspheres
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.
Polyvinyl Alcohol Embolic Microspheres 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 |
|---|---|---|---|
| PB-101 | — | Not stated | Available |
| PB-102 | — | Not stated | Available |
| PB-103 | — | Not stated | Available |
| PB-201 | — | Not stated | Available |
| PB-202 | — | Not stated | Available |
| PB-203 | — | Not stated | Available |
| PB-401 | — | Not stated | Available |
| PB-402 | — | Not stated | Available |
| PB-403 | — | Not stated | Available |
| PB-601 | — | Not stated | Available |
| PB-602 | — | Not stated | Available |
| PB-603 | — | Not stated | Available |
| PB-801 | — | Not stated | Available |
| PB-802 | — | Not stated | Available |
| PB-803 | — | Not stated | Available |
| PB-1051 | — | Not stated | Available |
| PB-1052 | — | Not stated | Available |
| PB-1053 | — | Not stated | Available |
| PW-101 | — | Not stated | Available |
| PW-102 | — | Not stated | Available |
| PW-103 | — | Not stated | Available |
| PW-201 | — | Not stated | Available |
| PW-202 | — | Not stated | Available |
| PW-203 | — | Not stated | Available |
| PW-401 | — | Not stated | Available |
| PW-402 | — | Not stated | Available |
| PW-403 | — | Not stated | Available |
| PW-601 | — | Not stated | Available |
| PW-602 | — | Not stated | Available |
| PW-603 | — | Not stated | Available |
| PW-801 | — | Not stated | Available |
| PW-802 | — | Not stated | Available |
| PW-803 | — | Not stated | Available |
| PW-1051 | — | Not stated | Available |
| PW-1052 | — | Not stated | Available |
| PW-1053 | — | Not stated | Available |
FDA clearances
- 510(k) K250209 September 2025
Procedures that use embolic beads
Frequently asked questions
What is Polyvinyl Alcohol Embolic Microspheres 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 Polyvinyl Alcohol Embolic Microspheres?
Polyvinyl Alcohol Embolic Microspheres is made by Canyon Medical Inc.. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does Polyvinyl Alcohol Embolic Microspheres come in?
The FDA device database does not list sizes for Polyvinyl Alcohol Embolic Microspheres. Check the instructions for use or ask a Canyon Medical Inc. representative.
Is Polyvinyl Alcohol Embolic Microspheres MRI safe?
The FDA device database entry for Polyvinyl Alcohol Embolic Microspheres does not state its MRI safety status. Check the labeling before MRI.
Is Polyvinyl Alcohol Embolic Microspheres FDA cleared?
Polyvinyl Alcohol Embolic Microspheres is covered by FDA submission K250209.
How do I contact a Canyon Medical Inc. sales representative?
Canyon Medical Inc. has not listed representatives on LA Vascular yet. Visit the Canyon Medical 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.