NMPA Approves Medtronic's PulseSelect PFA System for Atrial Fibrillation Treatment in China

Recently, the National Medical Products Administration approved Medtronic's PulseSelect system – "Cardiac Pulsed Field Ablation Generator" and "Single-Use Cardiac Pulsed Field Ablation Catheter," two innovative product registration applications.

Its cardiac pulsed electric field ablation system consists of a generator, controller (optional), footswitch (optional), EGM cable, and a single-use catheter interface cable; the single-use cardiac pulsed electric field ablation catheter consists of electrodes, a catheter body, and a handle.

The above two products are used in conjunction, utilizing the non-thermal effects of pulsed electric fields to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with episodes lasting less than one year). Compared with traditional radiofrequency ablation and cryoablation products, this product achieves selective destruction of myocardial tissue, avoiding the risk of damage to surrounding tissues caused by temperature conduction.

Catheter ablation has become one of the main treatment methods for atrial fibrillation. In terms of specific technical approaches, the currently available catheter ablation methods are mainly radiofrequency ablation and cryoablation.

Radiofrequency AblationUsing heat generated by radiofrequency current to destroy specific areas in heart tissue for the treatment of atrial fibrillation. Specifically, radiofrequency ablation delivers radiofrequency energy through a catheter to the abnormal area, increasing the temperature of local myocardial tissue, causing protein denaturation and coagulative necrosis of myocardial cells, thereby blocking the conduction of abnormal electrical signals and restoring normal heart rhythm.

CryoablationThis involves using a cryoballoon catheter to generate extremely low temperatures to destroy abnormal areas in heart tissue. The therapy delivers refrigerant to the affected area of the heart through a specialized catheter. The refrigerant evaporates at the tip of the catheter, absorbing a large amount of heat, which rapidly lowers the temperature of the surrounding tissue, thereby freezing and destroying the heart tissue in contact with the balloon. During the repair process, the damaged cardiac muscle cells form scar tissue, blocking the conduction of abnormal electrical signals.

Both of the above methods create damaged areas in tissues through thermal effects, lacking tissue selectivity. They not only alter the target cardiac tissue but may also harm surrounding tissues such as the esophagus, phrenic nerve, and pulmonary veins, posing a risk of complications.And the technology path of pulsed electric field ablation has solved this problem.。

Pulsed Field Ablation: A Treatment Method Applying Irreversible Electroporation Technology to Cardiac Ablation

Medtronic began researching the application of irreversible electroporation technology in surgical procedures in 2006. Since 2014, the research focus shifted to endocardial ablation, laying the foundation for the PulseSelect PFA system. The PulseSelect PFA system consists of the PulseSelect PFA circular catheter, which has both ablation and diagnostic functions, and the PulseSelect PFA generator, which is used to deliver pulse voltage, primarily for the treatment of atrial fibrillation.

PulseSelect PFA System Sets New Safety Standards for Paroxysmal and Persistent Atrial Fibrillation Ablation, Supported by 15 Years of Strong Preclinical and Clinical Evidence and One of the Safest Investigational Device Exemption (IDE) Atrial Fibrillation Ablation Trials to Date.

On December 13, 2023, Medtronic announced that the FDA had approved the PulseSelect PFA System for the treatment of paroxysmal and persistent atrial fibrillation (AF). It is reported that,This is the first PFA technology to receive FDA approval., having previously obtained European CE certification in November.

PulseSelect PFA System provides rapid and effective pulmonary vein isolation (PVI) through consistent and predictable energy delivery and catheter manipulation. The system is designed to enable clinicians to seamlessly transition to PFA within their preferred workflow. The safety and efficacy of the PulseSelect PFA System are supported by the PULSED AF study, which demonstrated a 0.7% rate of safety events and an 80% clinical success rate in patients with paroxysmal and persistent atrial fibrillation.

PulseSelect Generator HasAutomatic Overcurrent Detection Function, which can automatically detect and prevent excessive current transmission, thereby ensuring safety during the treatment process and avoiding unnecessary damage to heart tissue;R-wave Synchronization FunctionThis ensures that the energy transmission is coordinated with the natural rhythm of the heart, ensuring that energy is delivered at the appropriate phase of the cardiac cycle, enhancing treatment efficacy and minimizing interference with the heart’s normal rhythm.

PulseSelect PFA Catheter Equipped with 9 Electrodes for Sensing, Ablation, and Pacing, Featuring a 25mm Diameter Ring and 9 Fr Bidirectional Control Shaft, Enabling Full Visualization on Existing Mapping Systems and Imaging Tools. Its Fixed Electrode Spacing Ensures Electric Field Stability for Predictable and Consistent Continuous Energy Delivery; the 20-Degree Forward Tilt Design Increases Electrode-Tissue Contact Area to Ensure Uniform Energy Distribution. Additionally, the System Can Isolate All Pulmonary Veins Within Less Than 30 Seconds of Total Energy Delivery Time.

At the same time,PulseSelect PFA System is also the first PFA technology to receive FDA Breakthrough Device Designation.The PulseSelect PFA system also includes the following features:

• Designed as a plug-and-play system, PulseSelect can be used with any mapping system or with fluoroscopic imaging alone.

• Built-in safety features, such as diaphragmatic nerve test pulses, which are non-therapeutic low-voltage pulses used to pre-evaluate the proximity of the catheter to the diaphragmatic nerve before delivering therapeutic applications.

• The fixed spacing of the nine-electrode catheter generates a predictable and consistent electric field for continuous ablation. In addition to ablation, the nine electrodes can also be used for pacing and sensing.

• The small 9Fr bidirectional catheter enhances maneuverability and access to various anatomical structures, and is compatible with 10Fr sheaths, including the customized bidirectional FlexCath Contour™ sheath.

In May 2024, Medtronic Japan Co., Ltd. (Headquarters: Minato-ku, Tokyo) announced that the PulseSelect™ Pulsed Field Ablation System has received regulatory approval for the treatment of atrial fibrillation and drug-resistant symptomatic persistent atrial fibrillation. The company has begun the insurance application process to provide treatment under insurance plans in the future.

According to Frost & Sullivan, the market size of PFA in China is expected to reach 1.3 billion yuan by 2025 and maintain rapid growth, reaching 16.3 billion yuan by 2032, with a CAGR of 43.73% during this period. The proportion of China's PFA market size in the overall electrophysiology device market is also expected to increase continuously, rising from 8.18% in 2025 to 38.87% in 2032.

Currently, PFA products from two Chinese manufacturers have been approved for marketing.

On December 27, 2023, Jinjiang Electronics' Pulsed Field Ablation System received marketing approval from the National Medical Products Administration (NMPA), becomingThe First Pulsed Field Ablation Product Approved for Marketing by NMPAIts LEAD-PFA Cardiac Pulse Field Ablation Instrument can monitor the impedance of internal and external circuits, ensuring the safety of pulse delivery. The system offers various preset ablation protocols, is simple and quick to operate, and can flexibly adapt to different surgical scenarios. Additionally, the system has optimized parameters, resulting in almost no muscle twitching response and minimal patient pain.

On March 11, 2024, Deno EP announced that its key PFA product, CardiPulse, had been approved for marketing.The First Petal/Basket-Shaped Catheter to be Listed in ChinaThe CardiPulse pulsed electric field ablation system consists of a disposable cardiac pulsed electric field ablation catheter, a steerable sheath, and a cardiac pulsed electric field ablation generator. The 6-petal design allows CardiPulse to adjust to multiple configurations during clinical use to accommodate different pulmonary vein locations.

Data from the CardiPulse multicenter registry clinical study (PLEASE-AF Study) showed an immediate pulmonary vein isolation success rate of 100% during the procedure, and a 12-month postoperative atrial fibrillation ablation success rate of 86.7% (124/143), demonstrating the effectiveness of CardiPulse in treating patients with paroxysmal atrial fibrillation. The incidence of major adverse events (MAE) related to the device or procedure within 3 months post-surgery was 0.7% (1/143), proving the safety of CardiPulse in treating patients with paroxysmal atrial fibrillation, meeting current clinical safety requirements for atrial fibrillation catheter ablation products.

In addition, other Chinese innovative companies are also accelerating the layout of PFA products. The PFA products of companies such as HT Medical, MicroPort EP, and Maiwei Medical have entered the clinical enrollment stage.