Healthcare Industry News: dialysis
News Release - October 22, 2008
Merit Medical Announces 510(k) ClearanceSOUTH JORDAN, Utah, Oct. 22, 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, announced today that it has received 510(k) clearance from the FDA for the Prelude(tm) Short Sheath Introducer.
This device, which is used primarily for access to dialysis fistulas and grafts, provides several advantages for clinicians, including a marker tip to easily identify the exact placement of the device and an angled large-bore side arm for enhanced removal of blood clots. It will replace an existing product that is currently manufactured by an outside vendor.
``Prior to this introduction, the existing product was available only in the United States and Canada,'' said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. ``Our new, internally manufactured product has the features and benefits needed for us to become a market leader. We believe this product will allow us to compete worldwide with substantially improved margins in a market that continues to be an area of focus for Merit.''
Sales will commence worldwide in the next few weeks.
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 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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