CardioTech adds smaller size to artificial heart bypass graft trial
This article was originally published in Clinica
Executive Summary
CardioTech International has received US FDA approval to add a 4mm graft to the European clinical trial of its artificial heart bypass vessel, CardioPass. The 10-patient study, which started around 15 months ago, previously used only a 5mm graft. Eric Walters, the Wilmington, Massachusetts firm's vice-president and chief financial officer, told Clinica that including the smaller size will widen the pool of patients eligible for enrolment. The firm hopes to report results within a year, which, if positive, will support CE marking of CardioPass for sale in Europe. CardioTech will then consider applying for FDA clearance, Mr Walters said.