Medtronic Wins FDA Nod for Affera with Sphere-9 Early Feasibility Study

Medtronic announced U.S. Food and Drug Administration (FDA) approval to conduct an early feasibility study of its Affera mapping and ablation system with Sphere-9 catheter to treat sustained ventricular tachycardia (VT), an abnormal heart rhythm affecting the heart’s lower chamber.
 
The Affera mapping and ablation system with Sphere-9 catheter is an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-density mapping catheter used in cardiac electrophysiology ablation procedures.
 
The study will evaluate treatment with Sphere-9 and Affera for patients suffering from VT because of scarring from a prior heart attack. The study’s primary endpoints are rate of device- or procedure-related serious adverse events following ablation, and acute effectiveness at ablating the targeted VT. Patients enrolled in the study will be followed for six months after ablation.
 
Medtronic said the early feasibility study will add to promising preclinical data in VT and extensive research showing Sphere-9’s efficacy and safety to treat persistent atrial fibrillation (AFib). Sphere-9 received CE mark approval in 2023 to treat persistent AFib and is investigational in the U.S.
 
“Physicians need better tools to treat VT safely and effectively,and early feasibility research is a positive step toward determining potential new options,” said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. “I am pleased to be involvedin the study and look forward to getting started.”
 
“We look forward to learning more about how the Sphere-9 Catheter, which offers physicians the ability to map and ablatewith the option of choosing PF or RF, together with a large lattice-tip for managing the large target areas for ablation that typically present with VT, can be a useful tool for this challenging arrythmia,” added Khaldoun Tarakji, MD, MPH, VP and chief medical officer of Medtronic’s Cardiac Ablation Solutions business. “Currently approved treatments for VT involve only RF energy and require physicians to use multiple mapping and ablation catheters with often long, inefficient procedure times. PFA technology and the innovative Sphere-9 design could have a significant impact on patient care.”