Boston Scientific's FARAWAVE NAV Becomes First PFA Catheter with Integrated Mapping Function Approved by FDA

Oct 19, 2024 16:31 CST Updated 16:31

Boston Scientific

Medical Device Manufacturer

Boston Scientific announces its new generation of PFA products---FARAWAVE NAVApproved by the FDA for marketing, applicable for the treatment of paroxysmal atrial fibrillation (AF).

Expert Evaluation

"In clinical use, the FARAVIEW software and FARAWAVE NAV ablation catheter generate detailed cardiac maps, which can improve guidance, limit fluoroscopy time, and help doctors assess the location of energy delivery during PFA procedures."Adding navigation and visualization features to the FARAPULSE PFA can improve workflow efficiency and enhance the treatment provided by physicians for atrial fibrillation patients.”

---Vivek Reddy Mount Sinai Fuster Heart Hospital

Executive Evaluation

"Adding the FARAWAVE NAV ablation catheter and FARAVIEW software to our product portfolio provides a higher level of pulse field ablation mapping experience with cost-effective tools specifically developed for FARAPULSE PFA. Built on this safe and clinically proven platform, which has been used to treat more than 125,000 patients worldwide, the visualization capabilities offered by these new technologies are designed to increase confidence in treatment delivery and streamline the mapping workflow during PFA procedures."

---Nick Spadea-Anello, President of Electrophysiology at Boston Scientific Corporation

PFA products, like traditional radiofrequency ablation catheters, also requireUseSeparate mapping catheter for examinationAnd analyze the electrical patterns of the heart, and plan treatment applications for each patient. Therefore, the industry believes that only by excelling in 3D mapping systems can the true efficacy of PFA ablation be realized.

Therefore, how to perfectly integrate PFA products with the 3D mapping system has become the pursuit goal in the integrated electrophysiology field. Last year, the FDA approved a series of Johnson & Johnson's radiofrequency ablation products for performing ablations without fluoroscopy, ushering in a new era of electrophysiology. Johnson & Johnson is currently recognized as the sole leader in the 3D mapping field, but it is relatively behind Boston Scientific and Medtronic in the PFA field. However, when it comes to integrating PFA with 3D mapping, Johnson & Johnson, Boston Scientific, and Medtronic are on the same starting line.Its latest generation PFA ablation catheter, Omnypulse, is equipped with enhanced mapping capabilities (TRUEref). TRUEref enables the catheter to achieve higher precision and more detailed mapping abilities while improving signal quality.

Medtronic also owns its own 3D mapping system through the acquisition of Affera, and has integrated mapping functionality into its PFA products (Sphere-9, Sphere-360).

Boston Scientific, as the pioneer of PFA, also possesses the OPAL HDx 3D mapping system, which is second only to CARTO 3. This allows Boston Scientific to integrate its PFA products withThe integration of 3D mapping has become a natural progression, which is also the key reason Boston Scientific was able to be the first to launch a PFA product with mapping functionality (PFA approval).

FARAWAVE NAVThe emergence makes the entire ablation process simpler, more precise, and allows doctors to reduce radiation exposure. SupportingFARAVIEW software provides doctors with an intuitive mapping process, such as dynamic views of catheter placement, shape, and rotation, offering greater peace of mind during ablation procedures.

FARAWAVE NAV

FARAWAVE NAVIt is an upgrade based on the previous generation PFA product, FARAPULSE. Its appearance resembles the FARAPULSE ablation catheter (FARAWAVE), but it features magnetic positioning capabilities that the previous generation lacked, along with a dedicated 3D FARAVIEW module (software). This enables FARAWAVE NAV to have both ablation and mapping functions, making PFA ablation more precise, reducing fluoroscopy time, and helping doctors evaluate the location of energy delivery, with the aim of further improving patient outcomes.

Compared toFARAPULSE'sFARAWAVE NAV Advantages

Ablation Requires Only One Catheter

With the magnetic tracking FARAWAVE NAV pulsed field ablation catheter, doctors can collect geometry, perform ablations, and confirm workflows, eliminating the need for additional mapping catheters or extra catheter exchanges, using just one.FAThe RAWAVE NAV ablation catheter can complete left atrial ablation;

Dynamic Shape Visualization

FARAVIEW is specifically designed for the unique shape of the FARAWAVE NAV catheter, providing physicians with valuable insights to evaluate the ablation catheter.Shape, Positioning, and Rotation, which may potentially reduce the use of fluorescence during surgery.

Auto-labeling

FARAVIEW is equipped with an innovative marking tool that enables doctors to intuitively visualize PFA delivery, allowing them to plan, perform, and confirm ablations to support efficient procedures.

FARAWAVE NAVDemonstration

Boston Scientific

Boston Scientific commits to innovating for life. It is dedicated to innovative medical solutions, improving the lives of patients worldwide. For over four decades, Boston Scientific has consistently led the development of the global medical technology industry by providing a wide range of high-performance medical solutions. These solutions address urgent treatment needs for a broad patient population while reducing healthcare costs.