Kardium has collected an FDA approval for its pulsed field ablation approach to treating atrial fibrillation, giving it the go-ahead to compete in the emerging sector against heavyweights such as Boston Scientific, Medtronic and Johnson & Johnson.
The regulatory green lights—which also include separate agency clearances for its heart-mapping software and other catheter components—help fully unlock Kardium’s war chest. In July, the company raised $250 million in venture capital to prepare for its U.S. commercial launch this year, adding on to the $104 million it obtained in 2024.
The Fierce 15 winner’s Globe system is designed to provide single-shot isolations of the pulmonary veins that lead into the heart, which serve as the origin points for most cases of the irregular heartbeat.
Once in place, the catheter expands into a sphere about three centimeters in diameter, which easily nestles into the funnel-shaped openings to the pulmonary veins. It’s studded with 122 individually controllable electrodes that record cardiac activity, measure tissue contact and ultimately deliver pulsed field ablation that disrupts heart muscle cells before damaging other nearby tissues.
“The FDA approval of the Globe System represents the most significant milestone in the life of Kardium,” CEO Kevin Chaplin said in a statement. “We are extremely proud of the achievements of the team to deliver on our mission of developing the best treatment for AF. The Globe System supports a personalized, efficient, and effective AF treatment.”
In a U.S. clinical trial presented earlier this year, the catheter took an average of about 25 minutes to isolate all four of the heart’s pulmonary veins—with about five total minutes of X-ray fluoroscopy—while touting a 100% procedure success rate and zero device-related complications. After one year, 78% of the 183 treated patients demonstrated freedom from afib.
A previous version of the Vancouver-based devicemaker’s Globe system received a European approval in 2020 for delivering traditional thermal ablation.
The company has also been exploring the catheter’s ability to create focused and linear ablations to expand its treatment reach as well as its potential to be folded down and redeployed into separate heart chambers to treat atrial flutter, the second-most common arrhythmia after afib.