has agreed to plead guilty to charges related to its neurovascular medical device, Onyx Liquid Embolic System
, and pay $17.9M, the Department of Justice announced today.
With super-selective catheter delivery in a fow-directed fashion, the n-butyl-2-cyanoacrylate (n-BCA) liquid embolic system (Trufill, Cordis Neurovascular) is approved by the Food and Drug Administration (FDA) for embolization of cerebral arteriovenous malformations (AVMs) (1).
A prospective, multicenter, randomized trial of the Onyx liquid embolic system and N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations.
Micro Therapeutics' products include the Sapphire line of embolic coils, the ONYX(R) liquid embolic system
, and a broad line of microcatheters, guidewires, and occlusion balloons that are utilized in the treatment of cerebral vascular disorders.