Liberté launch
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific introduces its second-generation paclitaxel-eluting coronary stent, Taxus Liberté, in 18 countries in Asia, Africa and South America, the company announces Jan. 17. The firm expects to earn a European CE mark in 2005. U.S. approval, based on the ATLAS clinical trial, is projected for early 2006. A Japan release is planned for later that year (1"The Gray Sheet" Oct. 25, 2004, p. 4). Separately, Boston Scientific announces Jan. 19 the one-millionth Taxus implantation; European and U.S. approvals were received in January 2003 and March 2004, respectively...
You may also be interested in...
Taxus Will Continue To Lead Coronary Stent Market, Boston Scientific Vows
Boston Scientific aspires to retain the number-one position in the coronary stent space over the next few years by consistently bringing next-generation products to market ahead of competitors
Boston Scientific Taxus Japan Launch Delayed Until Second Half Of 2006
Boston Scientific will begin a required Japanese premarket approval trial next year for its Taxus paclitaxel-eluting stent, incorporating a short-term endpoint of major adverse coronary events (MACE)
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.