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U.S. Department of Health and Human Services

Product Classification

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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 CodeOBA
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
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
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible