Medtronic has announced continued momentum regarding its Affera family of technologies for cardiac arrhythmia treatment, including promising data presented at the Heart Rhythm Society (HRS) annual meeting (23–26 April, Chicago, USA) and the start of a new trial to evaluate a broader population of atrial fibrillation (AF) patients.
Results from the ongoing early feasibility study evaluating the Affera mapping and ablation system and the Sphere-9 catheter for treatment of recurrent sustained monomorphic ventricular tachycardia (VT) after a heart attack were presented as a late-breaking clinical trial at HRS 2026. Patients treated at centres across the USA were followed for six months post-ablation. Results showed 65.5% of patients remaining free from VT recurrence at six months.
Medtronic describes the Affera mapping and ablation system with the Sphere-9 catheter as an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping system for use in cardiac electrophysiology ablation procedures.
A company press release details that, in recognition of a “critical unmet need”, the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Sphere-9 catheter in the treatment of VT, providing an expedited regulatory pathway for the technology.
“Physicians urgently need better tools for VT that are safe, effective, and increase procedure efficiency, so it’s exciting to see sustained outcomes for ischaemic patients treated with the Affera mapping and ablation system and the Sphere-9 catheter after six months,” said Vivek Reddy (Mount Sinai Health System, New York City, USA). “Moving this research forward to the IDE [investigational device exemption] trial and expanding the patient population to include non-ischaemic patients are positive next steps for VT patients.”
Also at HRS 2026, a new sub-analysis from the Sphere-360 European study demonstrated positive results related to durability of lesions in AF procedures in patients with left common pulmonary veins. Results showed 100% lesion durability, highlighting consistency across patients with varied anatomies. Previously reported durability data showed 98% per-vein and 93% per-patient durability through invasive remapping at 75 days post-ablation.
The Sphere-360 catheter is an all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for the treatment of paroxysmal AF, according to Medtronic. It has been approved in Europe and is investigational in the USA, with a US IDE trial underway.
Additionally, Medtronic has announced the first patient enrolment in Conquer-AF, a prospective, multicentre, interventional, non-randomised study to characterise the safety and effectiveness of the Sphere-9 catheter in patients with recurrent paroxysmal or persistent AF who have previously had an ablation procedure. The study is enrolling patients in the USA, Europe and Australia.
“Our robust clinical research programme reinforces our commitment to advancing safe, effective and efficient therapies to help physicians treat a wide range of cardiac arrhythmias, and improve patients’ lives,” commented Khaldoun Tarakji, 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.”
