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SCIMED ANNOUNCES FDA APPROVAL TO MARKET RALLY, ITS NEXT-GENERATION SINGLE OPERATOR EXCHANGE PTCA BALLOON CATHETER

 MINNEAPOLIS, May 12 /PRNewswire/ -- SCIMED Life Systems, Inc. announced today that it has received FDA approval to market its next- generation single operator exchange PTCA balloon catheter, RALLY(R).
 The RALLY catheter construction consists of a patent-pending hypotube shaft and a unique reinforcing wire design of the distal shaft segment, which provide for a high performance combination of pushability (the catheter's ability to transfer force from the proximal to the distal end of the catheter sothe balloon can be advanced through the vessel and across the obstruction) and trackability (the ability to follow the path of the arterial anatomy). The RALLY is designed to provide fast and convenient exchanges.
 Dale A. Spencer, president and chief executive officer, commented, "The RALLY catheter was well-received in a controlled, multi-center clinical study involving more than 125 patients. We are optimistic about its acceptance by physicians as it is systematically released to the worldwide market over the next few months, based on availability and in service requirements."
 Although the RALLY design is specifically excluded from royalties to Advanced Cardiovascular Systems, Inc. (ACS) under the Dec. 1, 1991 Settlement Agreement, the RALLY catheter is the subject, along with SCIMED's EXPRESS(R) catheter, of a patent infringement action brought by Schneider (U.S.A.) and Schneider (Europe) in which the plaintiffs allege infringement of U.S. Patent 4,762,129, and seek damages and injunctive relief. SCIMED is vigorously defending this action both on the basis of non-infringement and on the basis of invalidity of that patent. Currently, summary judgment motions are pending before the court on the issues of infringement, brought by the plaintiffs, and on the issue of potential damages, brought by SCIMED. The court could rule on these motions at any time. Of course, it is impossible to predict with certainty the outcome of this or any litigation.
 SCIMED Life Systems, Inc. develops, manufactures, and markets disposable medical devices, principally coronary and peripheral angioplasty catheters, for non-surgical treatment of cardiovascular disease. SCIMED's shares are traded on the NASDAQ National Market System under the Symbol SMLS.
 -0- 5/12/93
 /CONTACT: Karen J. Kelsey, Director, Investor and Public Relations 612-494-1329/
 (SMLS)


CO: SCIMED Life Systems, Inc. ST: Minnesota IN: MTC SU:

AL -- MN014 -- 7793 05/12/93 17:30 EDT
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Publication:PR Newswire
Date:May 12, 1993
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