FDA clears 38-mm DES from Boston Scientific

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Boston Scientific has received FDA approval to market its Taxus Liberte Long paclitaxel-eluting coronary stent system, a drug-eluting stent (DES) designed for long lesions.

At 38 mm, the company said the DES will provide doctors with an option to potentially reduce the number of stents used in more complex cases. The Taxus Liberte stent series is now available in 92 sizes, ranging from 2.25-mm to 4-mm in diameter and from 8-mm to 38-mm in length.

The Taxus ATLAS Long Lesion trial reported a significant 79 percent reduction in the rate of nine-month myocardial infarction (MI) for the Taxus Liberte Long stent as compared with the Taxus Express stent control (1.3 vs. 6.3 percent), according to Boston Scientific. At two years, the composite measure of cardiac death or MI showed a 63 percent reduction for the Taxus Liberte Long stent compared with the Taxus Express stent (3.5 vs. 9.4 percent). The rate of stent thrombosis at two years was zero percent for the Taxus Liberte Long stent and 0.8 percent for the Taxus Express stent.

The Natick, Mass.-based Boston Scientific said it plans to launch the product in August in the U.S. It received CE Mark approval in 2007.