The approval is for a second-generation stent - a sleeve-like device used to hold a diseases artery open like a scaffold - that is more flexible and easy to place in the patient than Boston Scientific's first-generation Taxus Express 2 product, already marketed in most markets around the world.
The Taxus Liberte is being rolled out in India, Southeast Asia, the Middle East, Latin America and South Africa, but is not yet approved in either Europe or the US, according to the company.
Stents are typically used to prevent the closure - or restenosis - of diseased arteries that have been cleaned out using during an agioplasty procedure, in which a balloon is placed into the affected area and inflated to force the vessel open. They have been used for years, but it is only in recently that drug-coated stents have reached the market, on the back of clinical data showing unprecedented efficacy in preventing restenosis as they inhibit the local changes in the vessel contributing to this process.
The launch of the second-generation stent gives Boston Scientific a lead in the market over J&J's Cordis unit, whose Cypher stent - delivering the drug sirolimus - competes with the Taxus Express 2.
J&J beat Boston Scientific to market with its first-generation stents by a year, giving it a lead in the marketplace. This situation has now been reversed, and gives Boston Scientific a valuable marketing advantage. Meanwhile, other companies with ambitions in the drug-eluting stent market, including Medtronic, Abbott Laboratories, and Guidant, have yet to put their first products on the market.
In terms of its drug delivery profile little has changed with the Taxus Liberte stent, but it has the advantage that it is more easily navigated through a patient's blood vessels and across lesions, so is easier to implant, and conforms to the patient's artery walls more readily.
Boston Scientific said it hopes to launch the system in Europe later this year. In the US, the company has started enrolling patients in the ATLAS clinical trial, which is designed to support US approval, so an introduction there will not take place before next year.