FDA Approves Boston Scientific's PROMUS Everolimus-Eluting Coronary Stent System
July 3, 2008 - Boston Scientific Corp. today said the FDA has approved the PROMUS Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease.
The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific under an agreement executed prior to the 2006 acquisition of the former Guidant Corp. by Boston Scientific. FDA approval clears the way for Boston Scientific to launch the PROMUS Stent immediately in the U.S.
The PROMUS Stent expands Boston Scientific's drug-eluting stent (DES) portfolio, which includes the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (in the U.S. and international markets) and the TAXUS Liberte Paclitaxel-Eluting Coronary Stent System (in international markets), making Boston Scientific the only company to offer physicians the choice of two distinct drugs (paclitaxel and everolimus) on separate DES platforms.
"The PROMUS Stent has shown outstanding deliverability, low late loss and the potential to reduce the need for re-interventions," said Ted Feldman, M.D., FSCAI, director of the cardiac catheterization laboratory at Evanston Northwestern Healthcare in Evanston, IL. "These benefits will make the PROMUS Stent an attractive new treatment option for U.S. physicians and their patients."
The company said the next-generation PROMUS Stent is a highly deliverable, made from cobalt chromium, which allows for thinner struts without sacrificing strength or visibility. The SPIRIT clinical trials indicate the combination of the polymer/stent platform and the controlled release of the everolimus drug results in excellent deliverability, a strong safety profile, low levels of late loss and improved efficacy.
Boston Scientificï¿½s PROMUS Stent and Abbott's XIENCE V Stent are identical products sold by the respective companies under different brand names. The PROMUS (XIENCE V) Stent is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (up to 28 mm long) with reference vessel diameter of 2.5 to 4.0 mm.
As a result of agreements related to its acquisition of Guidant in 2006, Boston Scientific shares the rights to everolimus-eluting stent technologies with Abbott, including the XIENCE V Everolimus-Eluting Coronary Stent System (marketed by Boston Scientific as the PROMUS Stent). The company will continue to market its internally developed paclitaxel-eluting TAXUS Stent Systems, which has been implanted in more than 4 million people. Boston Scientific is also developing paclitaxel- eluting, everolimus-eluting and bare-metal versions of its third-generation Element Stent, which uses a unique platinum-enriched alloy.
The PROMUS Stent is currently for sale in Europe and some other international markets.
For more information: .www.bostonscientific.com