InStent gets conditional investigational device exemption (IDE) for stent trial
This article was originally published in Clinica
Executive Summary
InStent has received conditional IDE approval to begin clinical trials of its coronary stent CardioCoil. A non-randomised 70-patient study will be conducted at five centres in the US and one in Israel. The trial could start by the end of the year, if InStent can satisfy the FDA's reservations.