Embolic beads
HydroPearl
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.
HydroPearl 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 |
|---|---|---|---|
| 8HP2S75 | — | MR Safe | Available |
| 8HP2S200 | — | MR Safe | Available |
| 8HP2S400 | — | MR Safe | Available |
| 8HP2S600 | — | MR Safe | Available |
| 8HP2S800 | — | MR Safe | Available |
| 8HP2S1100 | — | MR Safe | Available |
| HP2S0075 | — | MR Safe | Available |
| HP2S0200 | — | MR Safe | Available |
| HP2S0400 | — | MR Safe | Available |
| HP2S0600 | — | MR Safe | Available |
| HP2S0800 | — | MR Safe | Available |
| HP2S1100 | — | MR Safe | Available |
FDA clearances
- 510(k) K192684 January 2020
- 510(k) K150870 December 2015
Procedures that use embolic beads
Frequently asked questions
What is HydroPearl 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 HydroPearl?
HydroPearl is made by Microvention, Inc.. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does HydroPearl come in?
The FDA device database does not list sizes for HydroPearl. Check the instructions for use or ask a Microvention, Inc. representative.
Is HydroPearl MRI safe?
The FDA device database lists HydroPearl as MR Safe. Always follow the specific MRI conditions in the labeling.
Is HydroPearl FDA cleared?
HydroPearl is covered by FDA submissions K150870, K192684.
How do I contact a Microvention, Inc. sales representative?
Microvention, Inc. has not listed representatives on LA Vascular yet. Visit the Microvention, 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.