Biosense Webster, the cardiac mapping division of Johnson & Johnson (NYSE:JNJ), launched a trial to examine its nMARQ pulmonary vein isolation system under FDA investigational device exemption. The 1st U.S. patient was treated by electrophysiologist Andrea Natale at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, according to a press release.
The nMARQ is designed to treat paroxysmal atrial fibrillation, a condition that affects 20 million people globally, according to company statements. The ablation system uses multiple electrodes and an irrigated catheter to delivery energy to areas of the heart’s muscles associated with abnormal heart rhythms.
The reMARQable clinical study is slated to enroll approximately 400 patients at 50 sites in the U.S., Biosense reported earlier this month.
"We are excited about the start of the pivotal U.S. clinical trial for this innovative new technology," Biosense worldwide president Shlomi Nachman said in prepared remarks. "By combining the multi-ablation capability of nMARQ System with the proven irrigation technology and the unparalleled mapping accuracy of the CARTO 3 System, this new platform has been designed to reduce procedure time and complexity.”
The cardiac mapping maker is still under a 3-year pact to integrate GE Healthcare’s CardioLab system with Biosense Webster’s Carto 3 navigation system.