Navistar RMT Thermocool is back
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/Biosense Webster's magnetic irrigated catheter is re-approved for sale in the U.S., after a manufacturing problem delayed its U.S. debut. The device, manufactured by Johnson & Johnson/Biosense Webster and intended for use with Stereotaxis' Niobe magnetic ablation steering system, was initially OK'd in January 2008, but was pulled after the two firms identified char or coagulation forming in some catheters during the manufacturing process (1"The Gray Sheet" Aug. 11, 2008, p. 18). Stereotaxis is counting on the RMT catheter, which was relaunched in Europe last winter, to drive sales of Niobe. Unlike J&J's manual Navistar Thermocool and EZ Steer catheters, the RMT catheters are not yet approved to treat atrial fibrillation