Medtronic plc (MDT) announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera family of technologies, including the next-generation Sphere-360 single-shot pulsed field ablation or PFA catheter and the groundbreaking Sphere-9 combination mapping and dual-energy focal PFA catheter.
The company noted that results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform.
Medtronic plans to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year.
Additionally, in a sub-analysis from the Sphere Per-AF IDE study, results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients.
For More Such Health News, visit rttnews.com.
For comments and feedback: editorial@rttnews.com