Merit Medical Systems (South Jordan, UT) received the CE mark to begin offering its Embosphere Microspheres in Europe for relief of symptoms caused by Benign Prostatic Hyperplasia (BPH). An enlarged prostate is a common condition in older men, one treated through drugs and surgical procedures.
Merit’s Embosphere Microspheres offer a completely new treatment approach by effectively blocking blood flow in selected vasculature around the prostate, stunning the organ’s ability to grow. The microspheres are hydrophilic and their special shape helps prevent them from bunching together, providing predictable embolization post injection.
From the announcement:
Consistent with its leadership role among interventional radiologists, Merit will sponsor a Center of Excellence training program at a number of leading hospitals in Europe beginning this year to facilitate physician training. The FDA has also approved an Investigational Device Exemption for Merit’s international, multi-center, randomized clinical trial that will compare the results of prostatic artery embolization to transurethral resection of the prostate (TURP) for treatment of BPH.
“Embolotherapy has long been recognized as an option for patients who seek an alternative to surgical procedures and pharmacotherapy to resolve their symptoms,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Embosphere enjoys an exceptional reputation in IR procedures such as Uterine Fibroid Embolization. Merit is delighted to expand Embosphere’s reputation and utility with the CE Mark for prostatic artery embolization.”
Product page: Embosphere Microspheres…
Press release: Merit Medical Receives CE Marking for Prostatic Artery Embolization for Embosphere(R) Microspheres