Angeion gets defibrillator study approval:
This article was originally published in Clinica
Executive Summary
Angeion has been granted an investigational device exemption for its Sentinel 2010 implantable cardioverter defibrillator system. The company recently received FDA permission to expand its trial of the Sentinel 200 to 25 sites. Both devices have CE marking in the European Union. The 2010 is the first Angeion defibrillator to store ECG data and has enhanced programming features.