NATICK, Mass., Boston Scientific Corporation today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its 2.25 mm PROMUS^® Everolimus-Eluting Coronary Stent System for use in vessels as small as 2.25 mm in diameter.  The Company plans to immediately launch the product in the U.S.

The PROMUS Stent features a thin-strut, open-cell design to allow for excellent flexibility and conformability in the vessel.  The low-profile stent and catheter tip help enhance deliverability, especially in small vessels.  The PROMUS Stent is supported by the SPIRIT clinical trial program, which demonstrates that the controlled release of everolimus results in low levels of late loss and a strong safety profile.  The addition of this stent expands the available size matrix of Boston Scientific's PROMUS Stent portfolio to include diameters from 2.25 to 4.0 mm and lengths from 8 mm to 28 mm.

"The PROMUS Stent has demonstrated outstanding deliverability, low late loss and excellent safety in numerous clinical trials and extensive real-world practice," said Dean J. Kereiakes, M.D., FACC, Medical Director, The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, and Professor of Clinical Medicine, Ohio State University.  "These benefits make the PROMUS 2.25 mm Stent an attractive option for U.S. physicians treating patients with small vessels."

"The approval of the 2.25 mm PROMUS Stent further expands our leading drug-eluting stent portfolio, which includes both everolimus and paclitaxel-eluting stents for the treatment of small vessels and long lesions," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific.  "In 2008, we became the first company to introduce a dedicated small-vessel stent and have led this segment ever since.  An everolimus-based, small-vessel stent allows physicians even greater flexibility in treating a variety of complex coronary lesions."

Data from clinical studies have shown that an estimated 10 percent of patients undergoing percutaneous coronary interventions have small vessels (<2.5 mm).  The 2.25 mm PROMUS Stent joins the 2.25 mm ION™ Paclitaxel-Eluting Platinum Chromium Stent as the Company's approved drug-eluting stenting options for small vessels.  

The PROMUS Stent is a private-labeled XIENCE V^® Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific.  PROMUS is a trademark of Boston Scientific Corporation or its affiliates.  XIENCE V is a trademark of the Abbott Laboratories group of companies.  The SPIRIT clinical trials are sponsored by Abbott.  

Source: Boston Scientific Corporation