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March 7, 2013
Merit Medical's Embosphere Microspheres Approved in Europe for Prostatic Artery Embolization
March 7, 2013—Merit Medical Systems, Inc. (South Jordan, UT) announced that it has received CE Mark approval 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. Merit advised that it will sponsor a Center of Excellence training program at a number of leading hospitals in Europe to facilitate physician training beginning this year.
Merit also announced that the US Food and Drug Administration has approved an investigational device exemption for the company's international, multicenter, randomized clinical trial that will compare the results of prostatic artery embolization to transurethral resection of the prostate for treatment of benign prostatic hyperplasia.
According to the company's press release, 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.
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