Cook Zilver goes global
This article was originally published in The Gray Sheet
Executive Summary
Paclitaxel-eluting peripheral stent safety and efficacy to be studied in 760-patient, 50-site trial in Europe, Asia, Australia and Canada. Enrollment for a 60-patient pilot trial, which could be converted to a pivotal study to support a PMA for the Zilver PTX stent for femoropopliteal arteries above the knee, is ongoing in the U.S. (1"The Gray Sheet" Feb. 14, 2005, p. 27)...
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Cook enters iliac stent market
Zilver vascular stent gains PMA approval June 26 for treatment of iliac arteries, allowing for a planned roll-out by early fall. The Cook device joins Cordis' SmartStent, approved in 2003, as the only self-expanding nitinol stents with the iliac indication. "Until recently, physicians have had limited options in treating vascular disease in the iliac arteries," says Zilver ZIPS trial investigator Barry Katzen, MD. The pivotal study evaluated 151 patients at 24 U.S. sites. Privately held Cook estimates that the iliac segment is worth $187 mil. in the U.S. out of a total vascular stent market of $630 mil. Cook also is developing Zilver PTX, a paclitaxel-eluting stent for femoropopliteal arteries above the knee (1"The Gray Sheet" May 9, 2005, In Brief)...
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