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FDA grants de novo clearance for Merit Medical’s Embosphere

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Merit Medical's EmboSphereMerit Medical (NSDQ:MMSI) said yesterday that its Embosphere device won expanded de novo clearance from the  to treat benign prostatic hyperplasia.

The federal safety watchdog’s clearance means Embosphere can be used in prostatic artery embolization  procedures to treat BPH.

“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 BPH,” chairman & CEO Fred Lampropoulos said in prepared remarks.

The device is designed to occlude the prostatic arteries to shrink the prostate and improve BPH symptoms, South Jordan, Utah-based Merit said.

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