Japanese approval for St Jude's Durata defibrillation lead
This article was originally published in Clinica
Executive Summary
St Jude Medical's Durata defibrillation lead has received regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW). Reimbursement approval for the high-voltage lead, used to implant an implantable cardioverter defibrillator in patients at risk of ventricular tachycardia, was also granted. The Durata lead is, at 7 French, the smallest diameter high-voltage lead on the market. It has a soft silicone tip with a larger surface area and a slightly curved right ventricle shock coil intended to enhance ease of use. It also incorporates Optim, a hybrid insulation material developed by St Paul, Minnesota-based St Jude specifically for cardiac leads.