Healthcare Industry News:  endoscopy 

Devices Urology Regulatory

 News Release - March 7, 2013

Merit Medical Receives CE Mark for Prostatic Artery Embolization for Embosphere(R) Microspheres

SOUTH JORDAN, Utah, March 7, 2013 -- (Healthcare Sales & Marketing Network) -- Merit Medical Systems, Inc. (MMSI), a leading manufacturer and marketer of proprietary implantable as well as disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received the CE Mark (Conformité Européenne) in the European Union to market its line of Embosphere(R) 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," 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."


Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 130 individuals. Merit employs approximately 2,750 people worldwide with facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Malvern, Pennsylvania; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Copenhagen, Denmark; and Rockland, Massachusetts.

Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted revenues, net income, financial results or anticipated acquisitions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2012. Such risks and uncertainties include risks relating to Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future transactions; product recalls; product liability claims; expenditures relating to research, development, testing and regulatory approval or clearance of Merit's products and risks that such products may not be developed successfully or approved for commercial use; greater governmental scrutiny and regulation of the medical device industry; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; compliance with governmental regulations and administrative procedures; potential restrictions on Merit's liquidity or its ability to operate its business by its current debt agreements; possible infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; the potential of fines, penalties, or other adverse consequences if Merit's employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws and regulations; laws targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in, or failure to comply with, governing regulations; the effect of changes in tax laws and regulations in the United States or other countries; increases in the price of commodity components; negative changes in economic and industry conditions in the United States and other countries; termination or interruption of relationships with Merit's suppliers, or failure of such suppliers to perform; fluctuations in Euro and GBP exchange rates; Merit's need to generate sufficient cash flow to fund its debt obligations, capital expenditures, and ongoing operations; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's existing products obsolete; market acceptance of new products; volatility in the market price of Merit's common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in health care markets related to health care reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; uncertainties associated with potential healthcare policy changes which may have a material adverse effect on Merit; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2012 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.

Source: Merit Medical Systems

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