Medtronic plc (NYSE: MDT), a leader in healthcare technology, announced breakthrough results at the Heart Rhythm Society (HRS) 2024 Annual Meeting for its Affera Mapping and Ablation System with Sphere-9 Catheter. This system, designed for the treatment of persistent atrial fibrillation (AFib), has demonstrated significant safety and efficacy in the SPHERE Per-AF study, a pivotal trial under the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE).

Clinical Outcomes

The study compared the performance of the Sphere-9 Catheter against the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System. Results, also published in Nature Medicine, highlight the Sphere-9’s advanced capabilities in creating comprehensive ablation lesions necessary for treating AFib effectively.

Dr. Elad Anter, Director of the Arrhythmia Institute at Shamir Medical Center, Israel, commented on the results: “The data show Sphere-9 lattice tip technology enables physicians to create a wide circumferential pulmonary vein isolation, the cornerstone of any type of AFib ablation, and any set of desired ablation lesions, in a safe, effective and efficient manner.”

Enhancing Patient Safety and Treatment Efficacy

The Sphere-9 Catheter not only met primary safety endpoints with a rate of only 1.4% but also demonstrated a substantial reduction in procedural complexities. More than 95% of procedures using the Sphere-9 required only a single transeptal puncture, significantly higher than the 62% in the control arm.

Patients treated with the Sphere-9 Catheter enjoyed a 73.8% freedom from AFib, outperforming the 65.8% observed in the control group. The catheter’s dual-energy capabilities—pulsed field (PF) and radiofrequency (RF)—alongside its high-density (HD) mapping feature, offer a versatile and efficient solution for managing this complex condition.

Procedural Efficiency and Quality of Life Improvements

The Sphere-9 catheter not only reduces the time between first and last ablation and overall energy application time but also enhances patients’ quality of life by improving both mental and physical well-being.

Rebecca Seidel, president of Cardiac Ablations Solutions at Medtronic, emphasized the broader implications: “As pioneers in cardiac ablation treatment, we are thrilled to share these results providing excellent evidence for the use of this all-in-one catheter that can be used with no need to pull a second catheter.”

Regulatory Progress and Future Prospects

The SPHERE Per-AF trial, conducted across 23 sites in three countries, sets the stage for the next steps in regulatory approval. Medtronic has already filed for approval of the Affera Sphere-9 Catheter in the U.S. with the FDA, and the system received CE Mark approval in Europe in March 2023.

AFib affects over 60 million people globally and is a progressive disease that can lead to severe complications such as heart failure and stroke. The introduction of the Affera Mapping and Ablation System with Sphere-9 Catheter represents a significant advancement in the treatment of this prevalent condition.

Medtronic’s latest innovation in AFib treatment through the Affera Sphere-9 Catheter could potentially reshape the treatment landscape for atrial fibrillation. Its impressive clinical outcomes underscore its potential to significantly improve patient care and procedural efficiencies.

  Affera Sphere-9 Catheter, Atrial Fibrillation, Medtronic