Kardium announced today that it completed the first commercial procedures using its Globe pulsed field ablation (PFA) system.
These mark the first cases with Globe, a treatment for AFib, after its recent approval by the FDA. Last month, the FDA granted Globe premarket approval (PMA), plus 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software.
Dr. Devi Nair completed the inaugural U.S. procedures. Nair serves as chief of cardiac EP and EP research at St. Bernard’s Medical Center (Jonesboro, Arkansas).
“We are very excited to offer our patients access to this groundbreaking new technology,” said Nair. “The Globe pulsed field system gives me greater confidence that each lesion is delivered safely and effectively, to support better outcomes for my patients while also simplifying the procedure.”
More about the Kardium Globe platform
The system features a catheter with a 122-electrode array and advanced software. It 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.
Globe now competes in the PFA market with some major medtech names. Those include Medtronic (Affera), Boston Scientific (Farapulse) and Johnson & Johnson MedTech (Varipulse). Following these first successful procedures, Kardium plans to continue expanding commercial availability across the U.S.
“These first commercial procedures with the Globe System signal the beginning of a new era in AF treatment,” said Kevin Chaplin, CEO of Kardium. “We are proud to partner with leading physicians like Dr. Nair to bring the Globe Pulsed Field System into clinical practice allowing us to deliver a more personalized treatment for atrial fibrillation to improve long-term outcomes for patients.”
