Health Canada Grants Expanded Indication for Merit Medical’s Embosphere® Microspheres for Prostatic Artery Embolization
Prostatic Artery Embolization (PAE) is a minimally invasive alternative to surgery for patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)
SOUTH JORDAN, Utah – November 15, 2018 – Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announces that Health Canada has granted an application to expand the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) procedures for the treatment of symptomatic benign prostatic hyperplasia (BPH) in people with medication-refractory urinary obstructive symptoms who are poor surgical candidates or refuse surgical therapy.
PAE is a minimally invasive, nonsurgical treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), also known as enlargement of the prostate gland. During the procedure, Embosphere Microspheres are used to occlude the prostate artery, reducing the prostate’s volume and improving patients’ symptoms. Additionally, multiple clinical trials have demonstrated positive effect on erectile function scores, peak urinary flow, and post-void residual volume after the PAE procedure, with correlating reductions in prostate-specific antigen (PSA) levels.
“As a minimally invasive procedure associated with a low risk of sexual side effects, PAE has emerged as a viable option for treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia in appropriately selected patients. This approval provides patients with an alternative to pharmaceutical medical management and surgery, and allows interventional radiologists and other providers to discuss PAE with their patients,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.
To further support the growth of the procedure, and the safe and effective use of Embosphere Microspheres, Merit is committed to providing clinicians with opportunities for training and education about PAE. In addition to symposia and seminars offered at major medical conferences, Merit also sponsors specialized training through its ThinkPAE® education program as well as an online, comprehensive PAE Physician Resource center including both clinical and patient education resources (Merit.com/PAE).
Led by distinguished faculty and held at various locations throughout the United States during the year, ThinkPAE programs feature a blend of didactic lectures, hands-on training, and peer interaction intended to provide interested physicians with a thorough understanding about all aspects of the procedure, from patient work-up to post-PAE care.
Embosphere Microspheres are the only embolic approved by the Canadian regulatory agency for use in PAE procedures. In addition to the expanded indication in Canada, Embosphere Microspheres are approved in the United States for use in embolization of arteriovenous malformations, hypervascular tumors, symptomatic uterine fibroids, and the prostate arteries for relief of symptoms related to BPH. In the European Union, Embosphere Microspheres are indicated for use in hemostatic embolization and in embolization of arteriovenous malformations, hypervascular tumors, including uterine fibroids and meningiomas, and the prostate arteries for relief of symptoms related to BPH.
About Merit Medical
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 5,400 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore.
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