Boston Scientific Plans 2008 Post-Warning Letter Interventional Launches
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific plans to launch four new interventional cardiology products in 2008 after resolving a two-and-a-half-year-old company-wide FDA warning letter
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Taxus in Japan
Boston Scientific launches Taxus Liberté paclitaxel-eluting stent after gaining reimbursement from Japan's National Health Insurance System March 2. Taxus Liberté was approved by the Ministry of Health, Labor and Welfare Jan. 28, and is the "only second-generation drug-eluting stent in Japan," according to Boston Scientific (1"The Gray Sheet" Feb. 2, 2009, p. 15). The firm has pointed to Liberté as an example of accelerating approval times in Japan, where the regulatory pathway has historically been difficult to navigate for device makers. Abbott filed for Japanese approval of the Xience V everolimus-eluting stent in June. Boston Sci also markets its first-generation Taxus Express2 stent in Japan. Liberté was introduced in the U.S. last fall (2"The Gray Sheet" July 28, 2008, p. 10)
Taxus in Japan
Boston Scientific launches Taxus Liberté paclitaxel-eluting stent after gaining reimbursement from Japan's National Health Insurance System March 2. Taxus Liberté was approved by the Ministry of Health, Labor and Welfare Jan. 28, and is the "only second-generation drug-eluting stent in Japan," according to Boston Scientific (1"The Gray Sheet" Feb. 2, 2009, p. 15). The firm has pointed to Liberté as an example of accelerating approval times in Japan, where the regulatory pathway has historically been difficult to navigate for device makers. Abbott filed for Japanese approval of the Xience V everolimus-eluting stent in June. Boston Sci also markets its first-generation Taxus Express2 stent in Japan. Liberté was introduced in the U.S. last fall (2"The Gray Sheet" July 28, 2008, p. 10)
Boston Scientific Gains Approval Of Taxus Atom Stent For Small Vessels
FDA approval for two Boston Scientific Taxus Express2 stents signals the firm is finally coming out from under the company-wide warning letter that has prevented it from launching new products, and suggests the agency will soon approve its next-generation Liberté paclitaxel-eluting stent