Healthcare Industry News: hemodialysis
News Release - December 30, 2008
Merit Medical Announces Year-End DevelopmentsSOUTH JORDAN, Utah, Dec. 30, 2008 -- (Healthcare Sales & Marketing Network) -- Merit Medical Systems, Inc. (NasdaqGS:MMSI ), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, today announced four developments regarding products and approvals.
The Company said that it has acquired the rights for a radial artery compression device for an undisclosed amount. The device is used to maintain a given pressure following a cardiac procedure which allows early ambulation.
``Merit's Prelude(tm) radial sheath product has been one of our most exciting products this year,'' said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. ``The addition of this compression device technology goes hand in hand with what the Company believes is an accelerating trend in radial artery procedures. This new product has several proprietary features and should be available for sale during 2009, following further development and regulatory approvals.''
Merit also announced the acquisition of a device used for the removal of cuffed catheters, such as hemodialysis catheters, and other products, such as ports. The product has patents pending, 510(k) clearance from the Food and Drug Administration, and is sold as a stand-alone product as well as part of a kit. The Company did not disclose the purchase price.
``We believe this product has already been proven to be a device well regarded by clinicians,'' Lampropoulos said. ``The stand-alone and kit versions fit perfectly into Merit's existing point of sale and assist in the bundling and sale of other Merit products.''
Merit also announced that it has received 510(k) clearance from the FDA for Merit's Miser(tm) contrast management system. The product has patents pending and will be released during the first quarter of 2009.
``With the rising cost of health care, this product allows clinicians to more efficiently manage contrast media, which is a costly part of a diagnostic or interventional procedure,'' Lampropoulos said. ``We believe that this product will enhance both the stand-alone and kit segments of our business.''
Finally, Merit announced that it has received ISO 13485 certification of its facility in Richmond, Virginia, from BSI, Merit's European Notified Body.
``This approval will allow Merit to better balance our facility load and, more importantly, to build products in our Richmond plant which may be sold in countries requiring the CE mark in the future, namely the European Union,'' Lampropoulos said.
``This segment of our business has become increasingly important to our overall strategy,'' Lampropoulos added. ``We believe with the number of products and capabilities Merit possesses, our bundling and overall competitive position should be enhanced.''
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 and radiology. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 100 individuals. Merit employs approximately 1,650 people worldwide, with facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Maastricht and Venlo, The Netherlands; and Galway, Ireland.
Statements contained in this release, which are not purely historical, are forward-looking statements within the meaning of the Private Securities Litigation 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, 2007. Such risks and uncertainties include product recalls and product liability claims; infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; termination of supplier relationships, or failure of suppliers to perform; inability to successfully manage growth through acquisitions; delays in obtaining regulatory approvals, or the failure to maintain such approvals; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's products obsolete; market acceptance of new products; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; and fluctuations in and obsolescence of inventory; volatility of the market price of Merit's common stock; foreign currency fluctuations; changes in key personnel; work stoppage or transportation risks; modification or limitation of governmental or private insurance reimbursement; changes in health care markets related to health care reform initiatives; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2007, and other reports 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 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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