Boston Scientific Reports 177% Surge in Electrophysiology Sales Driven by Farapulse PFA System

On October 23, 2024, Boston Scientific Corporation announced its financial results for the third quarter of 2024.Net sales were $4.209 billionCompared with the same period last year, the performance of this year's third quarter increased by 19.4% as reported, 19.5% on an operational basis, and 18.2% on an organic basis.

Boston Scientific Q3 Performance (Source: Boston Scientific)

Notably, Boston Scientific CEO Mike Mahoney stated that the Farapulse Pulse Field Ablation (PFA) system has driven an increase in procedure volume for the electrophysiology business, with third-quarter sales rising compared to a year ago.Increased by 177%。

So far, more than 125,000 people worldwide have been treated with Farapulse, and it is expected that by 2026, this technology could account for 40%-60% of global atrial fibrillation ablation procedures. Next, Boston Scientific Corporation will submit the trial results of Farapulse in treating refractory, persistent atrial fibrillation to the FDA, aiming to expand the product's indications by the second half of 2025.

Farapulse Pulsed Field Ablation System is a treatment for drug-resistantRefractory, recurrent, symptomatic paroxysmal atrial fibrillationInstrument.

Previously, the main clinical approach wasRadiofrequencyAndFreezingTwo types of energy are used for ablation. However, both methods have drawbacks, the most critical being the non-selective ablation mechanism that may damage surrounding tissues. The Farapulse pulsed field ablation system is different. It delivers multiple short-duration, high-voltage electrical pulses to ablate cardiac tissue through irreversible electroporation, preserving the surrounding tissue structures while ablating the heart tissue. This method is characterized by higher safety and faster effectiveness.

Advantages and Disadvantages of Three Ablation Methods

Boston Scientific announced the launch of the Farapulse pulsed field ablation system in 2013, and it wasn't until January 2024 that it officially received FDA approval for market release. Boston Scientific has also become the first to complete the collection in the atrial fibrillation ablation field.Pulse Ablation, Radiofrequency Ablation, CryoablationTechnology Product Companies.

Notably, in July 2024, the FARAPULSE series of pulsed field ablation products, including the FARAWAVE single-use cardiac pulsed field ablation catheter and the FARASTAR cardiac pulsed field ablation system, received approval from the National Medical Products Administration. Boston Scientific became the first company globally to obtain such approval.FDA, CE, NMPAApprovalCompany for the Treatment of Atrial Fibrillation with Cardiac Pulsed Field Ablation System.

In the third quarter of 2024, not only did the number of Farapulse pulsed field ablation system procedures grow, but Boston Scientific also witnessed more breakthrough moments in the cardiovascular field.

·The FARAWAVE NAV ablation catheter and new FARAVIEW software for the treatment of paroxysmal atrial fibrillation have received FDA 510(k) clearance. These two technologies will provide visualization for cardiac ablation procedures using the FARAPULSE pulsed field ablation system.

·FARAPULSE Pulsed Field Ablation System Receives Approval from Japan's Pharmaceuticals and Medical Devices Agency for the Treatment of Paroxysmal Atrial Fibrillation

·ACURATE Prime Aortic Valve System Receives CE Approval. This system, developed by Boston Scientific, represents the next generation of transcatheter aortic valve replacement technology, designed to treat severe aortic stenosis in patients across all surgical risk levels while expanding treatment options to patients with larger anatomical structures.

·INGEVITY+ Pacing Lead Receives FDA Approval for Expanded Indications, Including Conduction System Pacing and Left Bundle Branch Area Sensing When Connected to Single-Chamber or Dual-Chamber Pacemakers.

·LUX-Dx II/II+ Insertable Cardiac Monitor System for Long-term Arrhythmia Monitoring Receives CE Approval.

Since its inception, Boston Scientific has focused on the cardiovascular device sector, creating representative star products in areas such as cardiac rhythm management, interventional cardiology, electrophysiology, structural heart disease, peripheral and oncology interventions. Judging from Boston Scientific's third-quarter results and publicly disclosed future plans, the FARAPULSE pulsed field ablation system will be one of the key products for future development.

According to a report by Future Market Insights, the global pulsed electric field ablation market saw a compound annual growth rate of 48.6% from 2021 to 2022, with the market size reaching $1.3 million in 2023. It is projected that the market size may exceed $11.7 million by 2033.

Following the approval of the FARAPULSE pulsed field ablation system, this sector has garnered even more attention. To date, four companies globally have received approval for their pulsed field ablation systems, respectively.Boston Scientific, Medtronic, Jinjiang Electronics, Deno EPAmong them, the one-time-use cardiac pulse field ablation catheter and cardiac pulse field ablation instrument developed by Jinjiang Electronics, and the CardiPulse pulse field ablation system from Denovo Electrophysiology, are all independently developed products made in China.

Four Approved Cardiac Pulsed Field Ablation Products

Jinjiang Electronics' "Disposable Cardiac Pulse Field Ablation Catheter" and "Cardiac Pulse Field Ablation Instrument"December 2023Approved by the National Medical Products Administration, it is the first pulsed field ablation product approved in China.

In addition to possessing all the advantages of traditional pulsed electric field ablation technology, this product is also integrated with Jinhjiang Electronics' proprietary LEAD-Mapping fully magnetic positioning 3D system. It combines 3D modeling, mapping, and ablation functions in one, and the surgical process does not require X-rays, significantly reducing occupational risks for surgeons.

And the CardiPulse Pulse Field Ablation System of Denuo ElectrophysiologyMarch 2024Officially approved by the National Medical Products Administration for marketing, it is China's first approved petal-shaped cardiac pulsed field ablation catheter with full independent intellectual property rights.

The petal-shaped design is the most prominent innovation of the CardiPulse pulsed electric field ablation system. CardiPulse adopts a six-petal flower design, with each petal containing three electrodes, and one additional positioning electrode added to one of the petals. The catheter's form is flexibly variable, available in three diameter specifications to accommodate different pulmonary vein structures, making it not only easy to operate but also improving the safety and effectiveness of the surgery.

Overall, in the field of cardiac pulsed field ablation, Chinese manufacturers are demonstrating significant innovation capabilities. Each product features unique designs and innovative advantages to meet diverse clinical needs. According to reports,Huitai Medical, Xuanyu Medical, Aikema Medical, Maiwei MedicalCompanies are deploying in this field. In the future, with the continuous advancement of technology and the expansion of market scale, more Chinese-produced enterprises will join in, providing more treatment options for atrial fibrillation patients.