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March 25, 2019

CardioFocus wins European approval for new system

Photo | Courtesy The HeartLight X3

Marlborough medical device maker CardioFocus has been granted European approval for a new atrial fibrillation system.

In a press release announcing CE Mark approval, as European health regulations are known, the company describes the HeartLight X3 System as a third-generation device that uses laser energy and balloon technology to enable uninterrupted, high-speed lesion creation under direct control of a physician. 

This allows for reduced procedure times. Trials found that the device has the potential to complete all required ablations in fewer than 20 minutes, the company said.

Commercialization of the device in Europe will begin immediately. Current users of the HeartLight platform can upgrade to the X3 technology.

The X3 technology is not yet approved for sale in the U.S.

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