On October 21st, according to foreign media Fierce Biotech, the FARAWAVE NAV ablation catheter and Faraview software integrated with Boston Scientific's navigation function have been approved by the US Food and Drug Administration (FDA).

It is reported that the above two products have been officially launched in the United States, forming part of the Boston Scientific Farapulse Pulsed Field Ablation (PFA) system, providing a new visualization solution for cardiac ablation surgery.

New features added
The FARAWAVE NAV ablation catheter is an upgrade based on the previous generation PFA product FARAPULSE. It looks very similar to the FARAPULSE ablation catheter in appearance, but the new generation product has many new features that were not present in the previous generation product - magnetic navigation function and equipped with a dedicated 3D FARAVIEW module (software).

Therefore, this also enables the FARAWAVE NAV ablation catheter to have both ablation and mapping functions:
 Ablation only requires one catheter: With the help of the magnetic tracking FARAWAVE NAV pulsed field ablation catheter, doctors can collect geometric shapes, ablation and confirm workflows, thereby avoiding the need for additional mapping catheters or catheter replacements. One 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 valuable insights for doctors to evaluate ablation catheter shape, positioning, and rotation, potentially reducing the use of fluorescence during surgery;
 Automatic tagging: FARAVIEW is equipped with a pioneering tagging tool that allows doctors to visually visualize PFA delivery so they can plan, execute, and confirm ablation to support efficient surgery.

In addition, the FARAVIEW software is used in conjunction with the FARAWAVE NAV ablation catheter to provide doctors with an intuitive display of the treatment process. This software dynamically displays the position, shape, and rotation of the catheter, allowing doctors to clearly observe the specific situation of ablation. This visualization technology enables doctors to evaluate the distribution of energy during the ablation process in real time, ensuring the accuracy of treatment.

In clinical use, FARAVIEW software and FARAWAVE NAV ablation catheter generate detailed cardiac maps, which can improve surgical guidance, shorten fluoroscopy time, and help doctors evaluate the location of energy application in PFA treatment, "said Dr. Vivek Reddy, Director of Cardiac Electrophysiology at Mount Sinai Fuster Heart Hospital in New York." The addition of these navigation and visualization capabilities can improve surgical efficiency and enhance doctors' confidence in providing treatment for atrial fibrillation patients.

Through this technology, Boston Scientific not only improves doctors' control over surgery, but also provides patients with safer and faster treatment options. FARAVIEW software integrates OPAL HDx ™ The cardiac mapping system enables Boston Scientific to provide a full process solution from diagnosis to treatment. This seamless integration enables doctors to monitor and adjust treatment strategies in real-time during the operation process, maximizing treatment effectiveness.

The emergence of FARAWAVE NAV has made the entire ablation process simpler, more precise, and doctors should consume less thread. The accompanying FARAVIEW software can provide doctors with intuitive mapping processes, such as dynamic views of catheter placement, shape, and rotation, which also makes doctors feel more at ease during the ablation process.

Leading competitive in global market
It is understood that the unique feature of the FARAWAVE NAV ablation catheter, FARAVIEW software, and FARAPULSE system approved by Boston Scientific this time lies in its comprehensive and integrated technology. Stifel analyst Wise has pointed out that although most FARAPULSE cases still use competitor mapping tools, Boston Scientific now provides a "one-stop service" through FARAWAVE catheters and integrated mapping systems, further consolidating its competitiveness in the market.

Previously, Boston Scientific's FARAPULSE system received FDA approval in January 2024. This time, by combining advanced technology with innovative products, it can quickly help Boston Scientific expand its advantages in the PFA field.

However, it is worth noting that Boston Scientific is not the first PFA company in the world to receive FDA approval for the treatment of AFib (atrial fibrillation). As early as December 2023, Medtronic's PulseSelect pulsed electric field ablation system had obtained FDA approval for the treatment of paroxysmal and persistent AFib, becoming the world's first FDA approved PFA product and occupying the market ahead of schedule.

Medtronic's PulseSelect pulsed electric field ablation system also has its unique advantages, with the biggest advantage being its wide range of indications. Like FARAPULSE from Boston Scientific ™ The series of pulsed electric field ablation products are only targeted at treating 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 also has multiple product advantages:
 Plug and play: PulseSelec pulsed electric field ablation system is a plug and play system that can be used with any mapping system, and even directly with X-ray fluoroscopy imaging;
 Built in safety function: Equipped with a diaphragm nerve test pulse, the voltage of the diaphragm nerve test pulse is very low. This test voltage can be used to evaluate whether the ablation catheter is close to the diaphragm nerve before starting the formal ablation process;
 Nine electrodes with fixed spacing: Due to the circular shape of the nine electrodes at the head of the catheter, the spacing between them is fixed, resulting in a consistent electric field for continuous ablation. In addition, these nine electrodes can also be used for pacing and sensing;
 Small catheter diameter: The ablation catheter has a small diameter of only 9Fr (with an outer sheath of 10Fr diameter), which facilitates easy entry of the catheter into various anatomical structures.

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

Source: https://news.yaozh.com/archive/44408.html