A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported that it has received approval from the FDA to market its Taxus Express2 Atom paclitaxel-eluting coronary stent system.

The company said the Atom is a highly deliverable drug-eluting stent (DES) specifically designed for treating small coronary vessels. It is the only DES approved by the FDA for use in vessels as small as 2.25 mm in diameter. No other DES for sale in the U.S. market is approved for use in vessels smaller than 2.50 mm in diameter, the company said.

Boston Sci said it plans to launch the product immediately.

The company also reported FDA approval of its Taxus Express2 DES for the treatment of in-stent restenosis in bare-metal stents. This is the first such approval granted by the FDA, making the Taxus Express2 stent system the only DES approved in the U.S. for the treatment of in-stent restenosis in bare-metal stents.

"The Taxus Express Atom stent will provide better options for U.S. patients with coronary artery disease in small vessels," said Gregg Stone, MD, chairman of the Cardiovascular Research Foundation and professor of medicine at Columbia University Medical Center (New York), the principal investigator of the Taxus IV and V clinical trials.

"This is a welcome addition to the range of available drug-eluting stents, since patients with small vessels who are currently treated with bare-metal stents experience high rates of restenosis," he said. "In the Taxus V clinical trial, the Taxus Express Atom stent significantly reduced the chance of restenosis and the need for repeat procedures compared to bare-metal stents, in patients with small vessel disease."