The FDA has given Boston Scientific the green light to market a drug eluting stent (DES) that’s indicated for use on vessels smaller than any other DES available.
The TAXUS Express Atom Stent 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 plans to launch the product immediately.
The Company today also announced FDA approval of its TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System 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 drug-eluting stent approved in the United States for the treatment of in-stent restenosis in bare-metal stents.
TAXUS stents have been evaluated by the industry’s most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, approximately 4.6 million TAXUS stents have been implanted globally, making them the world’s most frequently used drug-eluting stents.
Press release: Boston Scientific Announces FDA Approval of TAXUS® Express2™ Atom™ Stent System, First Drug-Eluting Stent For Small Vessels
Product page: TAXUS Express2 Atom Paclitaxel-eluting Coronary Stent System
