Y-90 microspheres
TheraSphere
by Boston Scientific Corporation
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
TheraSphere 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 |
|---|---|---|---|
| M00139552US0300 | — | MR Safe | Available |
| M00139552US0350 | — | MR Safe | Available |
| M00139552US0400 | — | MR Safe | Available |
| M00139552US0450 | — | MR Safe | Available |
| M00139552US0500 | — | MR Safe | Available |
| M00139552US0550 | — | MR Safe | Available |
| M00139552US0600 | — | MR Safe | Available |
| M00139552US0650 | — | MR Safe | Available |
| M00139552US0700 | — | MR Safe | Available |
| M00139552US0750 | — | MR Safe | Available |
| M00139552US0800 | — | MR Safe | Available |
| M00139552US0850 | — | MR Safe | Available |
| M00139552US0900 | — | MR Safe | Available |
| M00139552US0950 | — | MR Safe | Available |
| M00139552US1000 | — | MR Safe | Available |
| M00139552US1050 | — | MR Safe | Available |
| M00139552US1100 | — | MR Safe | Available |
| M00139552US1150 | — | MR Safe | Available |
| M00139552US1200 | — | MR Safe | Available |
| M00139552US1250 | — | MR Safe | Available |
| M00139552US1300 | — | MR Safe | Available |
| M00139552US1350 | — | MR Safe | Available |
| M00139552US1400 | — | MR Safe | Available |
| M00139552US1450 | — | MR Safe | Available |
| M00139552US1500 | — | MR Safe | Available |
| M00139552US1550 | — | MR Safe | Available |
| M00139552US1600 | — | MR Safe | Available |
| M00139552US1650 | — | MR Safe | Available |
| M00139552US1700 | — | MR Safe | Available |
| M00139552US1750 | — | MR Safe | Available |
| M00139552US1800 | — | MR Safe | Available |
| M00139552US1850 | — | MR Safe | Available |
| M00139552US1900 | — | MR Safe | Available |
| M00139552US1950 | — | MR Safe | Available |
| M00139552US2000 | — | MR Safe | Available |
FDA clearances
- PMA P200029 March 2021
- PMA P110035 November 2018
Procedures that use y-90 microspheres
Frequently asked questions
What is TheraSphere used for?
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
Who makes TheraSphere?
TheraSphere is made by Boston Scientific Corporation. It is listed under y-90 radioembolization microspheres in our device library.
What sizes does TheraSphere come in?
The FDA device database does not list sizes for TheraSphere. Check the instructions for use or ask a Boston Scientific Corporation representative.
Is TheraSphere MRI safe?
The FDA device database lists TheraSphere as MR Safe. Always follow the specific MRI conditions in the labeling.
Is TheraSphere FDA cleared?
TheraSphere is covered by FDA submissions P200029, P110035.
How do I contact a Boston Scientific Corporation sales representative?
Boston Scientific Corporation has not listed representatives on LA Vascular yet. Visit the Boston Scientific Corporation 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.