CE Mark for Merit’s Embosphere Microspheres

Merit Medical Systems Inc. received CE Marking (Conformite Europeenne) in the European Union to market its line of Embosphere Microspheres for embolization of the prostate gland for relief of symptoms related to Benign Prostatic Hyperplasia (BPH).

Moderate to severe lower urinary tract symptoms (LUTS) due to BPH afflict approximately 50% of men aged 65 and older. At around age 50, the prostate gland – through which the urethra passes – grows large enough to constrict the urethra. For patients, quality of life decreases due to frequent urges to urinate and insufficient voiding. In some patients, these symptoms interrupt normal sleeping patterns, further degrading their quality of life. Ultimately, BPH can cause acute urinary retention. Current treatment solutions include pharmacotherapy options such as 5-alpha reductase inhibitors and/or alpha-adrenergic blockers. Surgical interventions such as trans-urethral resection of the prostate (TURP), prostatectomy or energy-based treatments such as laser or microwave are also options.

Prostatic artery embolization selectively blocks blood flow to the prostate resulting in reduced organ volume and reduced urethral stricture. Clinical data has demonstrated that patients achieve durable symptom relief while avoiding the complications and side effects associated with surgical or energy-based procedures and pharmacotherapy.

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," states Fred P. Lampropoulos, chairman and CEO, Merit. "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."