Boston Scientific announces European approval for Taxus Liberte

Boston Scientific has announced that its Taxus Liberte paclitaxel-eluting coronary stent has received European CE Mark approval for its use in patients with diabetes.

The decision means that the Taxus Liberte stent has more CE Mark-approvals than any other drug-eluting stent, with the stent also indicated for use in patients with angina, silent ischemia and acute myocardial infarction as well as with diabetes.

European approval is based on study results showing the stent to benefit diabetic patients with coronary artery disease.

Data from four Taxus Atlas trials supported the efficacy and safety of the Taxus Liberte stent in diabetic patients. The studies examined 1,529 patients who received treatment with the stent, 413 of whom had diabetes.

David McFaul, Boston Scientific senior vice-president, expressed the company’s delight in receiving CE Mark approval, stating that it was a “milestone” for the treatment of patients with diabetes.

“We are offering another specific solution for diabetic patients outside the United States, who are typically at higher risk for adverse events compared to non-diabetic patients,” he confirmed.

Earlier this month, Boston Scientific announced that it had signed an agreement to sell its fluid management and venous access businesses to private equity firm Avista Capital Partners for the total sum of $425 million (209.1 million pounds) in cash.