Embosphere microspheres improve treatment of enlarged prostate

Posted By : Enaie Azambuja
Embosphere microspheres improve treatment of enlarged prostate

 

Merit Medical Systems has announced that it has received 513(f)(2) (de novo) classification from the FDA to expand indication for Merit’s Embosphere Microspheres. The indication now includes prostatic artery embolisation (PAE) for symptomatic benign prostatic hyperplasia (BPH).

“Merit’s Embosphere is the first embolic agent to receive FDA 513(f)(2) classification for prostatic artery embolisation, providing a non-surgical treatment option for millions of men who suffer from BPH,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.

BPH is an enlarged prostatic gland and can cause lower urinary tract symptoms for more than half of all men in their 60s and as many as 90% of men over age 70.1 The PAE procedure is performed through a tiny incision in the patient’s upper thigh or wrist, and uses Embosphere Microspheres to occlude the prostatic arteries, reducing their blood supply and causing the prostate to shrink and improve symptoms.

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