Cook Medical is to recommence distribution in the United States of its Evolution® RL and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Sets following a two month suspension.
While neither of the devices, which remained available in Europe and other markets, was recalled by the FDA., the agency had questions about the marketing clearance of these products. Now apparently resolved, Cook is able to recommence sales of both the Evolution RL and Evolution Shortie RL. The devices are indicated for use in cardiac rhythm management patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Earlier this year, the Lead Management division launched an educational website on Cook’s role in supporting the development of the mechanical lead extraction procedure and the devices needed to perform these operations.
“For a quarter century, Cook has been at the forefront of cardiac lead extraction technology. Our latest devices in the Evolution RL line offer physicians the ability to control either uni-directional or bi-directional operation for mechanical extraction of problematic pacemaker and ICD leads and indwelling catheters,” said Louis Goode, vice president and global leader of Cook Medical’s Lead Extraction division. “We’re very pleased to be able to again provide these devices to U.S. physicians.”
Source: Cook Medical, Business Wire