The Canadian devicemaker Kardium has received European approval for its spherical heart ablation system designed to treat atrial fibrillation.
The company’s Globe catheter array consists of 122 individually controllable electrodes, allowing for single-shot ablation anywhere within the heart’s left atrium, as well as high-definition anatomical and electrical mapping of the organ.
The CE mark was based on results from a prospective clinical study published last September, showing 75.5% freedom from atrial fibrillation one year after a single treatment, and without antiarrhythmic drugs. Patients also demonstrated 100% pulmonary vein isolation, according to the company.
“This is an important milestone both for Kardium and the global AF community,” said CEO Kevin Chaplin. “The Globe System can now be used by electrophysiologists across Europe to safely and effectively treat patients with AF.”
The company has sales and support teams in place, through a new subsidiary in Germany, to begin the commercial and clinical launch of the system in Europe, Chaplin said.
In January 2019, Kardium raised an undisclosed amount of funding, led by accounts advised by T. Rowe Price, to bolster U.S. and European clinical studies and power the company’s commercial launch post-CE mark.