Medtronic’s Sphere-9 Catheter Earns FDA Breakthrough Nod; Shares Affera Milestones

Medtronic revealed continued momentum for its Affera family of technologies to treat cardiac arrhythmia, including positive data presented at the Heart Rhythm Society (HRS) annual meeting and the initiation of a new trial to assess a broader population of atrial fibrillation (AFib) patients.

Data from the ongoing early feasibility study evaluating the Affera mapping and ablation system and Sphere-9 catheter to treat recurrent sustained monomorphic ventricular tachycardia (VT) after a heart attack were presented as a late-breaking clinical trial. Patients were treated at U.S. centers and followed for six months post-ablation, with results showing 65.5% of patients remained free from VT recurrence at six months.

The U.S. Food and Drug Administration (FDA) granted breakthrough device status for the Sphere-9 catheter to treat VT, offering an expedited regulatory pathway.

“Physicians urgently need better tools for VT that are safe, effective, and increase procedure efficiency, so it’s exciting to see sustained outcomes for ischemic patients treated with the Affera mapping and ablation system and the Sphere-9 catheter after six months,” said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. “Moving this research forward to the IDE trial and expanding the patient population to include non-ischemic patients are positive next steps for VT patients.”

The Affera mapping and ablation system with the Sphere-9 catheter is a dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping system used in cardiac electrophysiology ablation procedures.

A new sub-analysis from the Sphere-360 European study was also presented at HRS, showing 100% lesion durability of lesions in AFib patients with left common pulmonary veins. Previous durability data demonstrated 98% per vein and 93% per patient durability through invasive remapping at 75 days post-ablation. The Sphere-360 catheter is a mapping and single-shot pulsed field ablation (PFA) catheter to treat paroxysmal AFib that’s approved in Europe and investigational in the U.S., with the U.S. IDE trial underway.

Medtronic also announced the first patient enrollment in Conquer-AF, a prospective, multi-center, interventional, non-randomized study to characterize the safety and effectiveness of the Sphere-9 catheter in patients with recurrent paroxysmal or persistent AFib who have previously had an ablation procedure. The study is enrolling patients in the U.S., Europe, and Australia.

“Our robust clinical research program reinforces our commitment to advancing safe, effective, and efficient therapies to help physicians treat a wide range of cardiac arrhythmias and improve patients’ lives,” said Khaldoun Tarakji, M.D., MPH, vice president and chief medical officer of Medtronic’s Cardiac Ablation Solutions business. “The encouraging results shown in this VT study underscore the versatility of the Sphere-9 catheter in treating a variety of different arrhythmias and the potential to advance care and outcomes for patients whose disease is often complex. With the Sphere-360 catheter, consistent durability across a wide range of patient anatomies is good news for patients and for physicians’ workflow.”