Interventional firm Guidant, along with medical supply and device manufacturer Cook, have filed an investigational device exemption application with the FDA to begin clinical trials for Cook’s paclitxel stent in the U.S. The stent incorporates drug-coating technology developed by the Bloomington, IN-based Cook. The stent and delivery system components are supplied by Indianapolis-based Guidant to Cook
Under terms of a distribution agreement between the companies, Guidant will be the exclusive worldwide distributor of the new stent, which will be manufactured by Cook. In addition, Guidant will manage the clinical trials and applicable regulatory submissions on behalf of Cook for the product.
By AuntMinnie.com staff writers
October 9, 2001
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