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CORDIS' APPROVALS FOR SLEEK, LIGHTNING, OLYMPIX LONG AND SLEUTH XT LONG

This article was originally published in The Gray Sheet

Executive Summary

CORDIS' APPROVALS FOR SLEEK, LIGHTNING, OLYMPIX LONG AND SLEUTH XT LONG dilatation catheters give the firm a line of 10 balloon angioplasty catheters (three fixed-wire and seven over-the-wire) cleared for marketing in the U.S. The company received notification from FDA on June 23 that its premarket approval supplements for the four devices were approved. Cordis currently is stepping up production of the catheters to meet worldwide demand. The four devices were all launched overseas within the last six months and are expected to be introduced in the U.S. in the next few weeks. The Sleek "represents Cordis' most advanced over-the-wire device...to date," the company says in a June 24 release. "The device's unique Trans Taper tip and low-profile balloon combine to provide the lowest diameter distal shaft of any comparable products currently available, rivaling even most fixed-wire systems." The company had received an approvable letter from FDA for the device in early May ("The Gray Sheet" May 10, In Brief). The Lightning fixed-wire PTCA catheter features an "ergonomic, torque control handle," which, according to the company, "enhances steerability," a trait that provides "easier access to and across the lesion to be treated." The shaft and balloon of the Lightning features a proprietary hydrophilic coating. The Lightning joins the Orion and Orion Soft Tip in the company's line of fixed-wire devices. The company notes that sales of the Lightning may lead to a phaseout of the Orion. The Olympix Long and Sleuth XT Long over-the-wire catheters, which are available in 3 cm and 4 cm lengths, represent longer models of the Olympix and Sleuth XT devices that were approved in December ("The Gray Sheet" Jan. 4, In Brief). Both devices accommodate up to .018 guidewires and feature "proximal and mid-balloon market bands that facilitate more precise balloon positioning," according to the company. In addition, Cordis notes, "both incorporate a special SLX coating that reduces friction"; the lubricating coating is present on both the inside and outside of the Olympix Long, but only on the inside of the Sleuth XT Long.
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