Benzinga | Mar 18, 2021 07:02AM EDT

Boston Scientific Receives FDA Approval For TheraSphere Y-90 Glass Microspheres

Boston Scientific Corporation (NYSE:BSX) announced it has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere(tm) Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC). The approval expands access to this life-prolonging therapy for a greater number of patients, which, to date, has been utilized under a humanitarian device exemption (HDE) -- an FDA classification which required institutional review board approval and limited the number of patients treated with the therapy per year. TheraSphere is now the only radioembolization technology indicated for the treatment of unresectable HCC in the U.S.