Medtronic Completes First Commercial Procedure with Sphere-9 Integrated PFA Ablation Catheter in the U.S.

Affera™ is an integrated,Dual-energy Pulsed Field (PF) and Radiofrequency (RF) Ablation System with High-density Mapping Function, used for cardiac electrophysiology ablation procedures. The system includesSphere-9, Energy Generator, and 3D Mapping Software.

• Sphere-9™ Catheter

• A novel 7.5Fr multi-segment grid-like spherical catheter with an expandable conductive lattice electrode.

• The catheter is inserted into the sheath in a folded form, and once inside the heart, the lattice expands.Spherical structure with a diameter of 9mm。

• Lattice contains9 itemsMicroelectrode/Temperature Sensor (diameter 0.7mm), evenly distributed on its surface, provides a larger effective ablation area.

• Allows doctors to switch between radiofrequency energy and pulsed field energy without moving the catheter and connection lines, meeting the ablation needs of different areas.。

  

• Energy Generator

• Capable of delivering pulsed field (PF) and radiofrequency (RF) energy,Used in conjunction with the Sphere-9 catheter,Provides dual-mode ablation capability。

• 3D Mapping Software (Prism-1)

• By using multiple position sensors at the catheter tip,Allow 6 degrees of freedom for position positioning, used for tracking and constructing three-dimensional maps of the heart chambers.
• Provides intuitive mapping and navigation, assisting doctors in selecting RF or PFA for large-area lesion ablation based on patient and surgical needs.

• Dual Ablation Modes:Allows intraoperative mode switching without the need to move the catheter and connecting lines, meeting the ablation needs of different sites.

• Lattice Tip Design:The lattice tip design of Sphere-9 (with 9 microelectrodes) is capable of delivering point-by-point ablation and can also be flexibly used in different anatomical locations, such as linear lesions.

• High Safety and Efficacy:On the one hand, selectively affecting myocardial cells,Without damaging the surrounding blood vessels and nerves, without damage to the esophagus and phrenic nerve; on the other hand,Linear block can reach up to 100% in the acute phase., the lesion at 35 days post-operation still presented as a continuous transmural injury.。

• Uniform and Efficient Delivery of Electrical Pulse Energy:Unique lattice tip design provides a larger effective surface area, delivering higher current to the tissue at a lower current density, increasing the safe and effective window for ablation, and offering advantages when used in special areas such as ventricular muscle.

# Mapping Ablation Superior to Johnson & Johnson

• Sphere-9 Catheter Has Good Safety，The primary safety endpoint rate was 1.4%.(1.0% in the control group)No safety events were reported, including pulmonary vein stenosis, esophageal events, or cardiac tamponade.
• More than 95% of Sphere-9 procedures utilized a single transseptal puncture, compared to 62% in the control group.。
• Sphere-9 Group73.8% The patient did not experience recurrence of atrial fibrillation., while the control group was only65.8 %。

• After 100% acute isolation of the pulmonary veins and linear lesions, receiveSphere-9 Catheter TherapyThe patients were also observed throughout the 12-month follow-up period.The recurrence rate of atrial arrhythmia is relatively low.。

• Compared with the control group, the treatment efficiency was higher with the use of the Sphere-9 catheter.Presented as:The time between the first ablation and the last ablationReduced by 26.8 minutes; Energy Application TimeReduced by 28.6 minutes。
• Patients treated with the Sphere-9 catheter showed improvements in both physical and mental health, as well as in quality of life.

This head-to-head trial indicates that Medtronic is attempting to disrupt the market as a latecomer.After all, electrophysiology giants Johnson & Johnson, Boston Scientific, and Abbott each possess their own three-dimensional mapping and navigation technology.

Johnson & Johnson's Thermocoll SmartTouchSF and Carto 3 systems have long been the industry standard for radiofrequency ablation in the treatment of atrial fibrillation. The Carto 3 system, with its rich set of functional modules and ability to integrate multiple mapping catheters, dominates the global three-dimensional mapping systems market and serves as the cornerstone for Johnson & Johnson’s leading position in the electrophysiology ablation field. However,Medtronic's Sphere-9 Catheter Demonstrates Higher Acute Success Rate in Clinical Trials, Somewhat Shaking Johnson & Johnson's Absolute Dominance in the 3D Mapping Field, which also means that Medtronic is determined to disrupt the competitive landscape of the market.

Medtronic is making a strong comeback with aggressive acquisitions and multiple new product approvals.

# How to Break Through

The commercial application of PFA in electrophysiology will become a rapidly growing field in the interventional industry in the coming years. To achieve commercial breakthroughs, it is necessary to focus on the following three points:

1. Original Technology (Product)

2. One-stop supporting services

3. Differentiated Design

Among themProduct strength and continuous innovation capability are key.。

Boston Scientific Considers Catheter Design Key to PFA Technology, OwnsThe Farawave catheter, featuring a variable basket and flower-like shapes, is designed to meet a broader range of arrhythmia treatment needs. The innovative catheter design ensures the correct electric field shape, appropriate waveform and energy, offering relatively high selectivity for cardiac tissue.

Abbott Focuses on Balloon-Designed PFA Catheters, which improves the accuracy and efficiency of ablation by increasing the contact area.Johnson & Johnson and Medtronic have adopted a dual-energy strategy., combining radiofrequency (RF) and PFA technology, PFA products are integrated with a three-dimensional mapping system, improving diagnostic efficiency.

Nowadays, with the continuous maturation and evolution of PFA technology, Chinese innovative enterprises have not only made breakthroughs in the field of three-dimensional mapping technology,Has even developed a PFA product that does not rely on 3D mapping technology.`, is expected to break the market pattern.`For example,Denovo EP's CardioPulse™ Pulsed Field Ablation ProductIts one-piece ablation electrode can achieve pulmonary vein contact with various anatomical shapes, enabling rapid and safe ablation of the pulmonary vein while providing high-quality electrical signal mapping.Pulmonary vein isolation can be performed without relying on 3D mapping, and has been approved for marketing by NMPA.In addition, the PFA products under research by companies such as NorthX Biotech and Ruidi Biotech also do not rely on a three-dimensional mapping system.

The global electrophysiology market has seen a full-scale intensification of competition, with the exception thatDisruptive innovation technologyOnly enough to break through the siege, and in this process, the figure of China's innovative power has already appeared. The future market competition is bound to be more diversified:A richer product selection, a more flexible pricing system, and a higher-quality service experienceAre all important factors for success or failure.