Kardium announced today that the FDA granted premarket approval (PMA) for its Globe pulsed field ablation (PFA) system.
Along with the PMA, the FDA granted 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software.
With the FDA nod, Kardium joins the hot U.S. PFA market that includes major medtech names like Medtronic (Affera), Boston Scientific (Farapulse) and Johnson & Johnson MedTech (Varipulse).
Kardium touts Globe as the only integrated, high-density cardiac mapping and ablation system that enables single-shot pulmonary vein isolation (PVI), plus customizable, targeted ablation, all in a single catheter. The company designed it to improve outcomes, streamline workflows and expand treatment options for AFib.
The Globe mapping and ablation system features a catheter that features a 122-electrode array and advanced software. The platform enables rapid PVI, high-definition mapping and the ability to ablate anywhere in the atrium. Globe catheter sensors provide proprietary Contact maps to identify electrodes in contact with cardiac tissue. This helps to ensure therapy for AFib is effectively delivered. The technology delivers just 1.2 applications per vein on average.
Earlier this year, the company shared data from its PULSAR IDE trial backing the Globe system. Kardium also raised $250 million for the platform in July.
“The FDA approval of the Globe system represents the most significant milestone in the life of Kardium,” said Kevin Chaplin, CEO of Kardium. “We are extremely proud of the achievements of the team to deliver on our mission of developing the best treatment for AFib. The Globe system supports a personalized, efficient, and effective AFib treatment.”
Chaplin discussed the Globe system during an episode of our DeviceTalks Weekly podcast last year:
