FDA grants de novo clearance for Merit Medical ’ s Embosphere
Merit 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.
The post FDA grants de novo clearance for Merit Medical’s Embosphere appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Urology Merit Medical Systems Inc. Source Type: news