| Device |
polymerizing, neurovascular embolization material |
| Definition |
The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ. |
| Physical State |
the embolization agent is dissolved in DMSO (dimethyl sulfoxide, an organic solvent); ethylene vinyl alcohol co-polymer (EVOH, the embolization agent) upon contact with aqueous solutions such as blood or saline, precipitates in situ forming a spongy/solid embolus - the micro-catheter is threaded up through the femoral artery into the brain and to the site of the aneurysm. The embolic solution (EVOH plus DMSO) is slowly infused, and thereby the material precipitates. |
| Technical Method |
intravascular embolization |
| Target Area |
intracranial aneurysms as specified by indication statement |
| Review Panel |
Neurology |
|---|
| Product Code | OBA |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
