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St. Jude Medical wins another CE Mark for cardiac ablation device

Fri, 06/18/2010 - 8:35am
Mass Device

By Brandon Glenn

St. Jude Medical Inc. (NYSE:STJ) won CE Mark approval in the European Union for a cryogenic cardiac ablation catheter.

The company said its Therapy Cool Flex is the industry’s first ablation catheter to have a flexible and irrigated tip, which could improve the device’s safety and efficacy, according to a press release.

Cardiac ablation involves scarring heart tissue to create lesions to interrupt the electrical signals that cause irregular heart rhythms. The device uses a coolant that freezes and destroys the tissue; its flexible tip allows it to bend to conform to the heart’s shape, according to the statement.

The CE Mark means St. Jude can market the device across the pond. The Therapy Cool Flex catheter has not been cleared for U.S. sales.

Earlier in the week, St. Jude announced receipt of the CE Mark for another ablation product, the EnSite Contact Technology platform which measures the amount of electricity that’s being used to create heart lesions.

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