SCIMED RALLY RAPID EXCHANGE PTCA BALLOON CATHETER APPROVED by FDA on May 4, providing the firm with a successor to its earlier generation Express. The approval gives Scimed approximately six months to position Rally before the company must discontinue U.S. marketing of the Express rapid-exchange catheter. Under the terms of a December 1991 settlement agreement with Lilly subsidiary Advanced Cardiovascular Systems, Scimed obtained a limited license to sell the Express in the U.S. until Nov. 30, 1993 ("The Gray Sheet" Dec. 2, 1991, p. 1). The settlement agreement stipulates that Scimed will pay royalties on sales of the Express and certain other catheters; royalties are not required on sales of the Rally. The Rally "single-operator-exchange" design includes a "hypotube" shaft, on which a patent is pending, and a "unique reinforcing wire design of the distal shaft segment," Scimed says in a May 12 release. The company claims that this construction increases both "pushability" -- the "ability to transfer force from the proximal to the distal end of the catheter so that the balloon can be advanced through the vessel and across the obstruction" -- and "trackability" -- the "ability to follow through the path of the arterial anatomy." Like the Express, the Rally can be exchanged without the use of an extension wire. Both products have similar balloon dimensions, but the Rally has a shorter lumen length and incorporates the "hypotube" technology, which is not present in Express. U.S. shipments of the Rally are expected to begin by the end of May, according to the firm. Scimed says that the Rally will be sold at a price comparable to that of the Express. Because the ACS licensing agreement does not prohibit overseas sales of the Express after Nov. 30, Scimed's initial marketing efforts for the Rally will focus on the U.S. The firm says, however, that it intends to market the product worldwide "over the next few months, based on availability and inservice requirements." While the Rally catheter is excluded from royalties to ACS under the settlement agreement, the company notes that both Rally and Express are included in a pending patent infringement suit brought by Schneider ("The Gray Sheet" Oct. 12, 1992, I&W-12). According to Scimed, summary judgment motions are currently "pending before the court on the issues of infringement, brought by the plaintiffs, and on the issue of potential damages, brought by Scimed." The company says that "the court could rule on the motions at any time."
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