Merit’s Embosphere Microspheres Receive Expanded Indication to Control Bleeding/Hemorrhaging in the Peripheral Vasculature
March 22, 2019—Merit Medical Systems, Inc. announced the FDA clearance of an expanded indication for its Embosphere microspheres for the embolization of blood vessels to occlude blood flow in the peripheral vasculature to control bleeding or hemorrhaging. It is the first spherical embolic device to be cleared for this use.
According to the company, Embosphere microspheres have now received more indications for use than any other spherical embolic on the market. With this approval, Embosphere microspheres are now indicated for use in embolization of arteriovenous malformations, hypervascular tumors, symptomatic uterine fibroids, prostatic arteries for the relief of symptoms related to benign prostatic hyperplasia, and for controlling bleeding/hemorrhaging in the peripheral vasculature.