April 16, 2007 - ev3 Inc. has received Humanitarian Device Exemption (HDE) clearance from the FDA for its Onyx HD 500 Liquid Embolic System for the treatment of intracranial aneurysms. This approval allows ev3 to commercialize its Onyx Liquid Embolic System to a population of patients with wide-necked cerebral aneurysms. The approval is limited to saccular, sidewall aneurysms with a dome to neck ratio less than 2mm that are not amenable to treatment with surgical clipping. ev3's Onyx 18 and 24 Liquid Embolic System received FDA approval in July of 2005 for the treatment of cerebral arteriovenous malformations.
Jim Corbett, CEO of ev3, commented, "We are delighted with the HDE approval of Onyx HD 500 as it provides physicians a new clinical tool to treat patients with wide-neck cerebral aneurysms who have very few therapeutic options. This approval further documents the unique therapeutic profile of our Onyx technology platform."
Cerebral aneurysms are vascular abnormalities in the brain that are characterized by a bulge in the wall of a blood vessel. These defects can cause severe neurologic symptoms, including death in the case of a rupture. A U.S. Investigational Device Exemption study and two European clinical studies closely examined the treatment of nearly 200 aneurysms, demonstrating that patients with wide-necked aneurysms were effectively treated with the Onyx HD 500 Liquid Embolic System. Wide-necked aneurysms occur in approximately 20 percent of the 17,000 patients that are treated each year in the U.S. with embolic coils.
Onyx HD 500 will be marketed in the U.S. by the ev3 Neurovascular sales force. As the first liquid embolic to be approved for the treatment of cerebral aneurysms, the release of Onyx HD 500 will be preceded by a lengthy period of education and training for a small group of leading neurovascular specialists. Once trained, this group of proctors will help insure that the use of Onyx HD 500 is carefully controlled as is required for all HDE approved devices.