Boston's "third-gen" drug-eluting stent reaches Europe
This article was originally published in Clinica
Executive Summary
Boston Scientific has CE marked Promus Element, its "third-generation" everolimus-eluting stent, for sale in Europe. It is made of a platinum chromium alloy, which offers greater radial strength and flexibility than older alloys such as cobalt chromium, the Natick, Massachusetts firm claims. Boston will begin marketing the device immediately in the EU and other CE mark countries. Promus Element is being evaluated in the 1,532-patient PLATINUM clinical trial, designed to support its US and Japanese approval. US FDA approval is expected in 2012. A trial of Boston's paclitaxel-eluting Taxus Element stent, which also employs the platinum chromium alloy, is due to report primary endpoint data in March 2010. CE marking of Taxus Element is expected in the second quarter of 2010, with FDA approval due to follow in 2011.