FDA Approves Narrow Everolimus-Eluting Stent

Reed Miller

May 31, 2011

May 31, 2011 (Silver Spring, Maryland) — The FDA has approved an extra-narrow everolimus-eluting stent that will be comarketed as Promus (Boston Scientific) and Xience Nano (Abbott Vascular) [1,2].

The approval is based on results of Abbott's SPIRIT Small Vessel study, in which patients with coronary vessels as narrow as 2.25 mm in diameter treated with the Promus/Xience Nano had late loss of 0.20 mm and a one-year target lesion failure rate of 8.1%, comparable with results of the larger SPIRIT clinical trials with the Xience V stent, according to the companies.

Promus/Xience Nano has been available in Europe since 2008; however, until now, the smallest everolimus-eluting stent available in the US was 2.5 mm in diameter. The new stent is appropriate for about 10% of drug-eluting stent recipients, both companies say.

The comarketing deal between Abbott and Boston Scientific is a legacy of Boston Scientific's 2006 acquisition of Guidant. To ensure the stent market remained competitive, the US government compelled Boston Scientific to sell Abbott the rights to also produce everolimus-eluting stents. Boston Scientific also continues to market paclitaxel-eluting stents, including the 2.25-mm ION paclitaxel-eluting platinum chromium stent.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....