Merit Medical has announced that it has received 513(f)(2) (de novo) classification from the FDA to expand indication for its Embosphere microspheres. The indication now includes prostatic artery embolization for symptomatic benign prostatic hyperplasia.
“Merit’s Embosphere is the first embolic agent to receive FDA 513(f)(2) classification for prostatic artery embolization, providing a non-surgical treatment option for millions of men who suffer from benign prostatic hyperplasia,” said Fred P Lampropoulos, chairman and chief executive officer of Merit.
