St. Jude Medical’s Durata ICD lead
This article was originally published in The Gray Sheet
Executive Summary
Firm strengthens its position as the only seller of size 7 French implantable cardioverter defibrillator (ICD) leads with FDA and CE-mark approvals of its Durata lead, announced Jan. 17. The next-generation Durata is the same size as St. Jude's Riata ST ICD lead, but includes a "softer tip and curved coil" to enhance ease-of-use, the firm says. Since Medtronic recalled its 7 French Sprint Fidelis lead in October, Riata ST has been the thinnest ICD lead on the market. A recent report by Morgan Stanley analyst Glenn Reicin suggests that St. Jude and Boston Scientific are gaining ICD market share from Medtronic as a result of the recall, but that the recall also has deterred many physicians from using any 7 French lead (1"The Gray Sheet" Jan. 14, 2008, p. 14). Separately, St. Jude announced Jan. 16 its receipt of FDA market clearance for its EnSite Fusion imaging software, allowing integration of heart chamber models created with the firm's EnSite system with three-dimensional computed tomography-derived models. The software displays cardiac electrical data to assist with diagnosis and treatment of abnormal atrial rhythms such as fibrillation, St. Jude says