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.