Medtronic Data Backs Sphere-360 Pulsed Field Ablation Catheter

Medtronic released positive clinical trial results for Sphere-360, its investigational, single-shot mapping and ablation catheter using pulsed field (PF) energy to treat paroxysmal atrial fibrillation (AF).
 
The Sphere-360 catheter was designed to simplify the AF procedure with better efficiency and high lesion durability, according to the company. It features a large, tissue-conformable lattice tip, which removes the need to rotate the catheter multiple times in one location as the whole lattice tup delivers PF energy.
 
The catheter is also integrated with Medtronic’s Affera mapping and ablation system for visualization inside the heart and electroanatomical mapping. Medtronic touts it as an all-in-one single-shot catheter for mapping, ablation, and validation.
 
The study evaluated 85 patients in three European centers. The subjects showed 81.8% freedom from atrial arrhythmias after one year of follow up, and 100% freedom in the sub-group treated with the optimized and most recent pulse configuration. The treatment time, or first to last PF application, was ten minutes on average.
 
A sub-study of patients treated with the optimized pulse underwent remapping procedures. 96% of those patients showed sustained lesion durability. Among all the pulmonary veins (PV) treated in this group, 99% remained isolated after 75 days of the index procedure.
 
The Sphere-360 PFA catheter also shows real-time local impedance info to address the catheter’s proximity to tissue. An over-the-wire design eases positioning in the vein, and it’s compatible with a small 8.5 Fr sheath.
 
“We have a vision to continually innovate and bring the best technology to AFib patients around the world, driven by our unwavering commitment to maximizing the safety and efficacy of our products,” said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer of Medtronic’s Cardiac Ablation Solutions business. “We are thrilled that the Sphere-360 study results validate our dedication to this goal: an all-in-one single shot mapping and pulsed field ablation catheter, that is fully integrated with the Affera Mapping and Ablation System, with a unique design that can conform to any pulmonary vein anatomy and can be used with an 8.5Fr sheath, single transeptal access and zero exchange. All these features make the procedure efficient and outcomes more predictable. We can’t wait for what’s next.”