Interventional device developer Boston Scientific has started a new clinical trial to evaluate the use of a slow-release formulation of its Taxus paclitaxel-eluting coronary stent system in high-risk patients. The Natick, MA, company said its Taxus V clinical trial will evaluate more than 1,100 patients at up to 70 sites in the U.S., with the study’s results used to support a regulatory filing for the Taxus product.
The Taxus V study will include patients with smaller vessels, as well as those with longer lesions requiring overlapping stents, according to Boston Scientific. The first patients were enrolled earlier this month. The company is already evaluating a slow-release version of Taxus in lower-risk patients in the Taxus IV study.
In other news, the company has submitted the second module of its premarket approval (PMA) application for Taxus to the Food and Drug Administration. It is the second of five modules the developer plans to submit. Taxus was released in Europe and other international markets in February this year, and the company plans on releasing it in the U.S. late in 2003.
By AuntMinnie.com staff writers
March 18, 2003
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