Kardium’s pulsed field system maps and stimulates cardiac tissue to treat AFib. Kardium named Medtronic’s Affera as the predicate for its pulsed field system. Boston Scientific’s Faradrive, which is used to deliver the Farawave PFA catheter, served as the predicate device for Kardium’s introducer sheath.

When deployed, the Globe system has a spherical array of 122 electrodes that map the environment and deliver PFA to ablate tissue. Users can focus energy delivery on electrodes that are in contact with tissue. 

A pivotal trial linked the system to a 78% one-year rate of freedom from atrial arrhythmia in paroxysmal AFib patients. The Mount Sinai Fuster Heart Hospital’s Vivek Reddy, who presented the data in April, told the Heart Rhythm Society’s media outlet that the result reflected pulmonary vein isolation durability. The trial found 95% of veins remained durably isolated.