CardioFocus lands CE mark for atrial fibrillation device

HeartLight Excalibur Balloon (Courtesy of CardioFocus)

CardioFocus has gained a CE mark for its HeartLight Excalibur Balloon. The regulatory nod clears the cardiac disorder specialist to start selling the atrial fibrillation device in the European Union later this year.

Marlborough, MA-based CardioFocus designed the balloon to build on its HeartLight Endoscopic Ablation System, which picked up an FDA approval last year. CardioFocus thinks the new features will improve the speed and extent of target tissue contact in pulmonary vein isolation procedures. 

To achieve these improvements, CardioFocus has added a remote so the doctor directly controls the sizing of the balloon and made other changes intended to make the device more responsive to the user’s actions. 

CardioFocus has also taken one of the defining features of its first-generation device—the balloon design intended to fit a range of patient anatomies and optimize contact—and sought to improve it. The result is a balloon CardioFocus says surgeons can rotate and reposition in the vein without fully deflating the device. CardioFocus has also designed the device to enable wide lesion sets and give users choice over its positioning. 

These features have been welcomed by at least one early tester of the device. 

“We consistently noted that the Excalibur Balloon is easier and faster to use, establishes significantly more contact with the vein and can consistently obtain an impressive antral position,” Petr Neužil, a professor at Na Homolce Hospital in Prague, Czech Republic, said in a statement.

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Neužil was part of the team that performed a live patient case using the device at a symposium at the start of the year. That case formed part of a clinical evaluation of the device that positioned CardioFocus to win the CE mark.

With the regulatory hurdle cleared, CardioFocus is now gearing up for a “controlled launch” in the EU. That is scheduled to begin in the fourth quarter.

In parallel, CardioFocus is working to grow sales of its first-generation device in the U.S. The cardiac specialist picked up a nod from the FDA last year and followed up with a $20 million equity round in March. That gave CardioFocus the financial muscle to intensify its commercialization efforts in the U.S. while pushing forward with development of Excalibur.