Effective immediately, Cook Medical customers in the United States will again have access to its Evolution RL and Evolution Shortie RL Controlled-Rotation Dilator Sheath Sets. Distribution of these products within the U.S. market was suspended for two months while Cook’s Lead Management clinical division worked with the U.S. Food and Drug Administration (FDA) to resolve agency questions about the marketing clearance of these products. The devices, which remained available in Europe and other markets, were not recalled by FDA.
“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.”
Both the Evolution RL and Evolution Shortie RL, he added, are indicated for use in cardiac rhythm management patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. See Instructions For Use.
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.