Medtronic has announced US Food and Drug Administration (FDA) approval to conduct an early feasibility study using the Affera Mapping and Ablation System for sustained VT, a serious heart condition.

Affera, including the Sphere-9 Catheter and the Affera Prism-1 Mapping Software, is an integrated system combining dual-energy pulsed field (PF) and radiofrequency (RF) ablation with high-density mapping, designed for use in procedures related to cardiac electrophysiology ablation.

The study aims to assess the Sphere-9 Catheter and Affera system in patients who have VT due to scarring from a previous myocardial infarction.

The primary endpoints will focus on the rate of serious adverse events related to the device or procedure and the acute success in ablating the targeted VT. Participants from various US centres will be monitored for six months after the ablation procedure.

Medtronic Cardiovascular Portfolio’s Cardiac Ablation Solutions business vice-president and chief medical officer Khaldoun Tarakji said: “We look forward to learning more about how the Sphere-9 Catheter, which offers physicians the ability to map and ablate with 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.

“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.”

This early feasibility study will leverage prior promising preclinical evidence in VT treatment and extensive research demonstrating the safety and efficacy of the Sphere-9 Catheter in managing persistent atrial fibrillation (Afib), a different type of arrhythmia.

The Sphere-9 Catheter was awarded the CE Mark in March 2023 to treat persistent Afib.