Boston Scientific’s Liberté Gains CE Mark
Boston Scientific Corp. (Natick, MA) announced that its Liberté drug-eluting coronary stent—described as the company’s next-generation Taxus—has been approved for sale in Europe and other international locations where the CE Mark is the regulatory standard.
The bare-metal version of Liberté was approved in Europe in December 2003, and by FDA in April of this year. Boston Scientific expects the drug-eluting version to gain U.S. market entry sometime in 2006.
Like Taxus, Liberté is coated with the drug paclitaxel, which is supplied to Boston Scientific by Angiotech Pharmaceuticals Inc. (Vancouver, BC). Drug-eluting stents, which are now used in more than 80% of coronary stenting procedures in the United States, have been found to be more effective than their bare-metal counterparts at preventing restenosis, or reclogging of the artery following angioplasty.
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Boston Scientific’s LaViolette: State-of-the-art stenting. |
Commenting on its approval by European regulators, Paul LaViolette, Boston Scientific’s chief operating officer said, “The Liberté stent system is designed to improve deliverability and conformability, providing physicians with state-of-the-art stent performance coupled with proven paclitaxel-eluting technology.”
According to the company, Liberté features thin struts for greater flexibility and deliverability, particularly in hard-to-reach arteries and other challenging anatomies. In contrast to Taxus’s stent struts of 0.0052 in., Liberté is 27% thinner at 0.0038 in. Using the Maverick 2 delivery catheter, the new stent provides a low-entry profile for better lesion crossability.
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Boston Scientific’s Best: Building market share. |
Lawrence Best, Boston Scientific’s executive vice president and CFO, said the company expects Liberté to “maintain and expand our market share.” While Boston Scientific’s Taxus drug-eluting coronary stent remains the worldwide market leader, it has lost ground to the Cypher stent from Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company. In the United States, its market share has declined from more than 70% shortly after introduction in March 2004 to around 59% today. The situation is even tighter in Europe, now that Medtronic Corp. (Minneapolis) has also received approval to market its drug-eluting coronary stent, Endeavor.
In the global coronary stent business, patent infringement suits—and countersuits—have become a kind of hallmark of market positioning. In the United States, the competitive landscape could become even more complex as a result of cross-litigation already under way. Analysts are closely watching patent infringement litigation between Boston Scientific and J&J’s Cordis, in which contrary rulings have already been issued.
This summer, juries in separate trials in a Delaware district court found that each company had violated the other’s patent, with one of the judgments ruling that the bare-metal version of Liberté infringed on a Cordis patent. Nick Valeriani, J&J’s worldwide chairman for cardiovascular devices and diagnostics, said he was “confident that the finding of infringement by the bare-metal Liberté stent will also apply to the drug-eluting version, and Cordis will strongly assert its patent claim against it if and when the product is launched.”
Backed by the other jury ruling in its favor, Boston Scientific does not appear unduly concerned about the matter, which is likely to be settled through negotiation.
Canon Communications LLC
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