Boston Scientific's new OPAL HDx 3D Mapping System officially approved

Recently, Boston Scientific announced that its new OPAL HDx cardiac electrophysiology three-dimensional mapping system has officially received approval from the National Medical Products Administration. The system is equipped with the FARAVIEW software module, which can be used in conjunction with the newly added magnetic navigation feature of the FARAWAVE NAV disposable magnetic navigation cardiac pulse field ablation (PFA) catheter to achieve three-dimensional cardiac mapping.

Currently, doctors may use a standalone mapping catheter before performing PFA procedures to examine and analyze the heart’s electrical conduction patterns, developing ablation plans for each patient. For example, in the United States, the application rate of three-dimensional mapping in atrial fibrillation catheter ablation procedures is as high as 80%-90%. The visualization capabilities of the 3D mapping technology help doctors observe catheter position, shape, and rotation angle in real-time, which is crucial for precise path planning and confirming ablation sites. It assists doctors in verifying pulse field delivery locations, reducing fluoroscopy time, improving surgical efficiency and confidence, and ensuring patient safety.

The FARAVIEW software module allows doctors to visually see the results of 3D mapping and ablation. It features the unique FieldTag pulse ablation marking function, which provides guidance for ablation strategies and assists doctors in planning, executing, and confirming ablation procedures. The phased results of the NAVIGATE-PF clinical study show that the FARAVIEW software module can provide accurate and reliable visualization support for evaluating both the acute and chronic phases of atrial fibrillation PFA treatment.

Gong Lingyun, Vice President of the Atrial Fibrillation Solutions Division at Boston Scientific China, stated that the FARAPULSE PFA system is the most widely used PFA product globally. The approval of this new 3D system marks that Boston Scientific now has a PFA system with more comprehensive indications, a closed-loop function, and complete expression capabilities, transitioning from an “energy advantage” to a “system advantage.” This further enhances the usability, safety, and accessibility of the FARAPULSE PFA system in PFA treatments, providing domestic electrophysiologists with a more complete diagnostic and therapeutic toolset. In the future, Boston Scientific will continue to improve its comprehensive atrial fibrillation solutions, bringing more treatment options to Chinese patients and doctors, and supporting the high-quality development of atrial fibrillation diagnosis and treatment.

The Boston Scientific FARAPULSE PFA system was approved in China in July 2024 for the treatment of drug-refractory, recurrent, and symptomatic paroxysmal atrial fibrillation, with indications expanding to include drug-refractory, symptomatic persistent atrial fibrillation patients by the end of 2025. The newly added magnetic navigation feature of the FARAWAVE NAV disposable magnetic navigation cardiac pulse field ablation catheter was also approved in China in December 2025.