Angiotech Gets FDA Approval For TAXUS

Angiotech Pharmaceuticals has received approval from the US Food and Drug Administration (FDA), to market its TAXUS Liberte Long Paclitaxel-Eluting Coronary Stent System. Its a next-generation drug-eluting stent (DES) designed for long lesions.

The 38 mm DES provides doctors an option that can potentially reduce the number of stents. It affords a treatment option for the estimated 8 to 10% of patients with long lesions. Boston Scientific plans to launch the product in the US next month.

Mark Turco, director of the Center for Cardiac Vascular, said: The TAXUS Liberte Long Stent offers physicians and patients distinct advantages compared to using two overlapping drug-eluting stents.

The TAXUS ATLAS Long Lesion trial reported a 79% reduction in the rate of nine-month myocardial infarction for the TAXUS Liberte Long Stent, as compared to the TAXUS Express Stent control (1.3% vs. 6.3%, p=0.026).

At two years, the composite measure of cardiac death or myocardial infarction showed a significant 63% reduction for the TAXUS Liberte Long Stent, compared to the TAXUS Express Stent (3.5% vs. 9.4%, p=0.0426). The rate of stent thrombosis at two years was nil for the TAXUS Liberte Long Stent and 0.8% for the TAXUS Express Stent.

Dr. William Hunter, president and CEO of Angiotech, said: Today’s approval of the TAXUS Liberte Long Stent, along with the approval of the TAXUS Liberte Atom Stent in May, demonstrates the strength and breadth of the paclitaxel platform.