ev3 announces FDA approval of treatment for brain vascular disorder

ev3 today announced that its majority-owned subsidiary Micro Therapeutics has received pre-market application (PMA) approval from the U.S. Food and Drug Administration (FDA) to commercialize its Onyx Liquid Embolic System (Onyx) for the treatment of arterio-venous malformations (AVMs), a vascular disorder in the brain.

MTI expects to commence immediately a controlled introduction of Onyx in the United States through its direct sales force. Onyx has been under development by MTI since 1995 and has been distributed in international markets by ev3 since 2002.

Arterio-venous malformations (AVMs) are blood vessel networks that abnormally connect arteries to veins. As a result of high blood flow and pressure imbalances, AVMs in the brain are at risk of hemorrhage, or rupture, which can lead to stroke, severe disability and even death. Treatment options for AVMs include catheter-based therapies, surgery, radiation therapy, or a combination of these treatments. Catheter-based treatments involve the delivery of embolic materials to occlude, or block, the abnormal blood vessels comprising the AVM.

Onyx is a liquid embolic material that is delivered by neurovascular specialists through MTI's proprietary micro catheters directly into a vascular defect, such as a brain aneurysm or AVM, in a very controlled manner. After delivery of the embolic material, the liquid quickly transforms into a solid polymer cast, thereby sealing off the vessels in the AVM from blood flow and reducing the risk of rupture. In the United States, Onyx is indicated for use in the pre-surgical embolization of brain AVMs. Endovascular embolization can reduce the size and vascularity of the AVM, thereby facilitating safer and easier surgical resection.

Gary Duckwiler, M.D., principal investigator in the pivotal clinical study of Onyx for AVMs, commented, "Onyx represents an important new cerebral AVM treatment option with its ability to facilitate a more deliberate and controlled embolization procedure." Dr. Duckwiler is the Director of Neuroradiology Fellowship Program, Division of Interventional Neuroradiology, and Professor of Radiology, UCLA Department of Radiological Sciences.