| Device |
hydrogel spacer |
| Definition |
To temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent to reduce the radiation dose delivered to the anterior rectum. |
| Physical State |
Synthetic, absorbable polyethylene glycol (PEG)-based hydrogel supplied in a single use tray |
| Technical Method |
Injected in tissue found between the rectum and prostate. The injected liquid solidifies creating a space between the rectum and prostate during radiation therapy to protect vulnerable tissue. It gradually liquifies and is absorbed. |
| Target Area |
Between the prostate and the rectum |
| Review Panel |
Radiology |
|---|
| Product Code | OVB |
|---|
|
Not Classified Reason
|
For Export Only
|
|---|
| Submission Type |
Contact ODE
|
|---|
| Device Class |
Not Classified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
