Boston Scientific "2 Medical Devices" approved by FDA

  The integrated FARAWAVE NAV ablation catheter and Faraview software have been approved by the U.S. Food and Drug Administration (FDA).

  The two products, which are officially available in the United States, form part of Boston Scientific's Farapulse Pulsed Field ablation (PFA) system, which provides a new visualization solution for cardiac ablation surgery.

  The FARAWAVE NAV ablation Catheter is an upgrade of the previous generation PFA product FARAPULSE, which looks very similar to the FARAPULSE ablation Catheter (FARAWAVE). However, the new generation of products has many new features that were not available in the previous generation of products - magnetic navigation and a dedicated 3D FARAVIEW module (software).

  Thus, the FARAWAVE NAV ablation catheter has both ablation and mapping functions:

  Only one catheter is required for ablation: With magnetic tracking of the FARAWAVE NAV pulse field ablation catheter, doctors can collect geometry, ablation and validation workflow, thus avoiding the need for additional mapping catheters or replacement of additional catheters. A single FARAWAVE NAV ablation catheter can complete left atrial ablation.

  Dynamic shape visualization: FARAVIEW is designed specifically for the unique shape of the FARAWAVE NAV catheter, providing physicians with valuable insights to evaluate ablation catheter shape, positioning, and rotation, potentially reducing the use of fluorescence during surgery;

  Automatic labeling: FARAVIEW is equipped with a first-of-its kind labeling tool that enables physicians to visually visualize PFA delivery so they can plan, perform, and confirm ablation to support efficient surgery.

  In addition, the FARAVIEW software is used in conjunction with the FARAWAVE NAV ablation catheter to provide physicians with an intuitive display of the treatment process. By dynamically displaying the position, shape, and rotation of the catheter, the software allows the doctor to clearly observe the ablation. This visualization technology allows physicians to assess the distribution of energy during ablation in real time, ensuring the accuracy of treatment.

  "In clinical use, the FARAVIEW software and FARAWAVE NAV ablation catheter generate a detailed cardiac map that can improve surgical guidance, reduce fluoroscopy time, and help physicians evaluate where energy is applied in PFA therapy," "The addition of these navigation and visualization capabilities can improve the efficiency of surgery and give doctors confidence in providing care for patients with atrial fibrillation," said Dr. Vivek Reddy, director of cardiac electrophysiology at Mount Sinai Fuster Heart Hospital in New York.

  With this technology, Boston Science not only improves the doctor's control over surgery, but also brings safer and faster treatment options to patients. The FARAVIEW software integrates the OPAL HDx™ heart mapping system, enabling Boston Scientific to provide a whole-process solution from diagnosis to treatment. This seamless integration enables physicians to monitor and adjust treatment strategies in real time during operation to maximize treatment effectiveness.

  The advent of FARAWAVE NAV makes the entire ablation process simpler, more delicate, and less time-consuming for doctors. The accompanying FARAVIEW software provides physicians with an intuitive mapping process, such as a dynamic view of catheter placement, shape, and rotation, which also gives physicians greater peace of mind during ablation.

  The FARAWAVE NAV ablation catheter approved by Boston Scientific is unique in its comprehensiveness and integration with the FARAVIEW software and FARAPULSE system. Stifel analyst Wise pointed out that while the majority of FARAPULSE cases currently use competing mapping tools, Boston Scientific now provides a "one-stop shop" with the FARAWAVE catheter and integrated mapping system, further consolidating its competitiveness in the market.

  Boston Scientific's FARAPULSE system was previously approved by the FDA in January 2024, and the combination of advanced technology and innovative products will quickly help Boston Scientific expand its advantages in the PFA field.

  However, it is important to note that Boston Scientific is not the first PFA company worldwide to receive FDA approval for the treatment of AFib (atrial fibrillation). As early as December 2023, Medtronic's PulseSelect pulsed electric field ablation system has been approved by the FDA for the treatment of paroxysmal and persistent AFib, becoming the world's first FDA-approved PFA product, occupying the market ahead of time.

  Medtronic's PulseSelect pulsed electric field ablation system also has its own unique advantages, the biggest advantage of which is its wide range of indications. Products such as Boston Scientific's FARAPULSE™ family of pulsed electric field ablation products are designed to treat drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation, but Medtronic's PulseSelect pulsed electric field ablation system can treat paroxysmal and persistent atrial fibrillation.

  In addition, Medtronic's PulseSelect pulsed electric field ablation system offers several product advantages:

  Plug and play: The PulseSelec pulsed Electric Field ablation system is a plug and play system that can be used with any mapping system, even directly with X-ray fluoroscopy.

Built-in safety features: It is equipped with phrenic nerve test pulse with low voltage, which can be used to assess whether the ablation catheter is close to the phrenic nerve before starting the formal ablation;

Nine electrodes with fixed spacing: Because the distance between the nine electrodes at the head of the catheter is fixed after forming a disc, the electric field generated is consistent, which facilitates continuous ablation. In addition, the nine electrodes can be used for pacing and sensing;

Small catheter diameter: The diameter of the ablation catheter is small, only 9Fr (with a 10Fr diameter sheath), which facilitates the catheter to easily enter various anatomical structures.

  In the treatment of AFib, both products have advantages. However, this time, Boston Scientific also demonstrated its strong technological innovation ability, consolidating its market position in the field of electrophysiology, and looking forward to more innovative products in the future.