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

June 18, 2010 by MassDevice staff

St. Jude Medical Inc. won another CE Mark from the European Union for a cardiac ablation device, this time for its Therapy Cool Flex catheter.

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By Brandon Glenn

St. Jude Medical Inc. (NYSE:STJ) won CE Mark approval in the European Union for a 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's 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.

*Correction, June 18, 2010: Due to a reporter's error, this article originally referred to the Therapy Cool Flex as a cryotherapy device, which it is not. Return to the corrected sentence.