Boston Sci gets OK from FDA to market ION DES

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The FDA has approved Boston Scientific’s ION paclitaxel-eluting platinum chromium coronary stent system, the company’s third-generation of drug-eluting stent (DES) technology.

Natick, Mass.-based Boston Scientific said that the ION stent system uses platinum chromium alloy to improve coronary stent implantation to treat coronary artery disease. The ION stent will offer greater deliverability and visibility and its thin-strut configuration was designed to improve conformability, minimal recoil and drug distribution.

The new stent delivery system includes both monorail and over-the-wire versions with sizes ranging from 2.25 mm to 4 mm and lengths of 8 mm to 38 mm.

The Ion stent system gained a CE mark in Europe in May 2010 and was marketed as the Taxus Element paclitaxel-eluting coronary stent system.

The approval was based on results of the PERSEUS and TAXUS ATLAS clinical trial, which enrolled 2,298 total patients and compared the Ion stent to prior-generation Boston Scientific stents. Results showed that the Ion stent had lower major adverse cardiac event (MACE) rates, target lesion failure and MI when compared to the Taxus Liberte paclitaxel-eluting stent system.