Telectronics Encor lead fractures prompt exit from atrial lead market.
This article was originally published in The Gray Sheet
Executive Summary
TELECTRONICS PLANS TO RE-ENTER ATRIAL PACER LEAD MARKET with redesigned passive and active leads following the devices' clearance by FDA, the company says. The new leads, which have not yet been submitted to FDA for review, are intended to replace the Encor and Accufix J-shaped leads. Cases of fracture have been reported for both devices, and they have been withdrawn from the market. The company currently is distributing substitute active and passive fixation atrial leads as replacements to the J-shape leads through an OEM manufacturer.