The Onyx HD 500 Liquid Embolic System for the treatment of intracranial aneurysms has just been cleared for a population of patients with wide-necked cerebral aneurysms. The clearance is limited to saccular sidewall aneurysms with a dome-to-neck ratio of less than 2mm that are not amenable to treatment with surgical clipping.
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 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.
Technology | June 11, 2007