Both picked up FDA approvals for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery.
Earlier this month, Medtronic said the FDA granted the indication for its Onyx liquid embolic system (LES) in the U.S. Onyx can now provide embolization of the middle meningeal artery (MMA) as an adjunct for surgery in treating SDH/cSDH.
Onyx LES, an ethylene vinyl alcohol (EVOH) copolymer, provides complete filling and distal penetration of peripheral lesions. It is delivered through a microcatheter under fluoroscopic control. The system’s non-adhesive properties enable more distal nidus embolization without the risk of catheter entrapment. Additionally, higher viscosities allow for controlled deployment. Medtronic also has a study underway for Onyx LES in the embolization of arterial hemorrhage in the peripheral vasculature.