Previously, distribution of the Evolution RL lead extraction products have been suspended in the US for two months following the US Food and Drug Administration’s (FDA) recall. The devices remained available in Europe and other markets.
Cook Medical’s Lead Management clinical division worked with the FDA to resolve agency questions about the marketing clearance of these products.
Cook Medical’s Lead Extraction division vice president and global leader Louis Goode said that for a quarter century, the company 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," Goode said.
"We’re very pleased to be able to again provide these devices to U.S. physicians."
The Evolution RL and Evolution Shortie RL controlled-rotation dilator sheath sets have been designed for use in cardiac rhythm management patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Image: Cook Medical’s Evolution Shortie RL controlled-dilator sheath. Photo: Courtesy of Business Wire
