Boston seeks US nod for Express stent trial:
This article was originally published in Clinica
Executive Summary
Boston Scientific has requested permission from the FDA to begin clinical trials of its Express coronary stent system in the US. The trials, which are expected to enrol 450 patients at 25 sites, are designed to assess the device's safety and efficacy in elective coronary stenting and for treating of abrupt and threatened abrupt vessel closure. The Natick, Massachusetts firm believes that the trials could start as early as next month.