Cook Medical Reintroduces Evolution RL Lead Extraction Products to U.S. Market
Cook Medical customers in the United States 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 FDA did not recall the devices, which remained available in Europe and other markets.
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.
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