Merit Medical’s Embosphere Microspheres Receive FDA De Novo Classification

Merit Medical Systems Inc., a manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, has received 513(f)(2) (de novo) classification from the U.S. Food and Drug Administration to expand indication for its Embosphere Microspheres. The indication now includes prostatic artery embolization (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 embolization, providing a non-surgical treatment option for millions of men who suffer from BPH,” said Fred P. Lampropoulos, Merit’s chairman and CEO.  
 
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 percent 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.
 
Founded in 1987, Merit Medical Systems develops, manufactures, and distributes proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 290 individuals. Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Va.; Malvern, Pa.; Rockland, Mass.; San Jose, Calif.; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore.
 
Reference
1. McWilliams, J. P., Kuo, M. D., Rose, S.C., Bagla, S., Caplin, D. M., Cohen, E. I., Faintuch, S., Spies, J. B., Saad, W. E., Nikolic, B. (2014). Society of Interventional Radiology position statement: prostate artery embolization for treatment of benign disease of the prostate. Journal of Vascular and Interventional Radiology, 25: 1349-1351. http://dx.doi.org/10.1016/j.jvir.2014.05.005  http://www.scvir.org/clinical/cpg/SIR_Pos_Statmt_PAE_Benign_dis_Prostate.pdf