Boston Scientific Completes First U.S. Commercial Cases with FARAPULSE Pulsed Field Ablation System Following FDA Approval

Feb 19, 2024 09:47 CST Updated 09:47

Boston Scientific

Medical Device Manufacturer

Source: Heart Future; Editor: Pan Yanyan

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Heart Future

As ofFebruary 15, 2024，Boston Scientific/Boston Scientific Corporation(NYSE: BSX)TheFarapulse Pulsed Field Ablation SystemAlreadyCompleted more than 30 commercial cases, andCompleted its operations in the United StatesFirst FDA Approval ObtainedClinical Cases Afterwards。

In a LinkedIn post, Nick Spadea-Anello, President of Cardiac Electrophysiology at Boston Scientific Corporation, announced this strategic milestone.Officially Launch Farapulse for the Treatment of Paroxysmal Atrial Fibrillation。

On January 31, 2024, Boston Scientific announced itsFarapulsePulse Field Ablation (PFA) System Receives FDA Approval。FarapulseThe PFA system is used to isolate the pulmonary veins during the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF)., is a unique new alternative to standard thermal ablation therapy. (For details, see:Revenue of 101.1 Billion! Boston Scientific's Latest Financial Report "Blooms in Two Areas"）

Nick wrote on social media, "Today, doctors across the United States are able to personally experience how this new therapy is transforming the field of ablation, offering patients with paroxysmal atrial fibrillation a safe, effective, and efficient treatment option."

Nick said,As of February 15, 2024, doctors have completed more than 30 commercial cases.He expressed special thanks to Dr. Andrea Natale and his team at Los Robles, as well as Dr. Wilbur Su and Dr. Roderick Tung and their teams at Banner Health, for allowing him to observe these cases.

"Thank you to everyone who has contributed to achieving this milestone," he concluded, "I look forward to continuing our joint efforts.Improving the Lives of Patients with Paroxysmal Atrial Fibrillation in the United States and Globally。”

#Farapulse Pulsed Field Ablation System

FARAPULSE is manufactured byHost FARASTAR, Ablation Catheter FARAWAVE, and Sheath FARADRIVEComposed of three parts.

FARAWAVEIt is a 12Fr diameter ablation catheter, with its distal end adoptingUnique flower-shaped design, with a total of 5 "petals," each "petal" equipped with 4 electrodes. The handle's slider can control whether the distal end forms a "flower bud" or a "bloom." When the 5 "petals" are fully open, they appear as flat petals; when partially open, they form a three-dimensional basket shape. The basket diameter can be adjusted via catheter telescoping.Available in two models with maximum flower diameters of 31mm and 35mm.。

FARASTARUseBipolar and Biphasic Waveforms as well as Proprietary Pulses. The interface is simple to operate,Only three buttons are needed to achieve a pulmonary vein vestibule isolation.。

FARADRIVEIt is a 13Fr distal steerable sheath that can better navigate FARAWAVE to the ostia of each pulmonary vein.

AndMedtronic's PulseSelectObtainedIntermittent and Persistent Atrial Fibrillation IndicationsThe difference in approval,The approved indications for Farapluse only coverParoxysmal Atrial Fibrillation, but Boston Scientific is also advancing Farapulse for persistent atrial fibrillationAVANT GUARD Clinical Trial, to evaluate the FARAPULSE™Pulsed Electric Field Ablation SystemAs the safety and efficacy of continuous atrial fibrillation (AF) as a first-line treatment, this is alsoCurrently the only oneClinical Trial Evaluating PFA for First-Line Treatment of Persistent Atrial Fibrillation。

#The Battle for Supremacy in the Atrial Fibrillation Market‍‍‍‍

FMIData shows,From 2021 to 2022, the global pulsed field ablation market experienced a compound annual growth rate of 48.6%, reachingThe market size reached 1.3 million US dollars in 2023。According to historical data, the market has been steadily growing with the adoption of modern technologies such as robot-assisted surgery and the reduction of invasive surgical techniques.

Technological advancements will continue to enhance the efficacy, safety, and minimally invasive nature of this procedure, and the market is expected to maintain an upward trend in the coming years.Boston Scientific Corporation previously estimatedPFA Will Dominate the Atrial Fibrillation Treatment Market in the Next Five Years, which has been strategically positioned early on.

On January 30, 2021, Farapulse, a subsidiary of Boston Scientific, announced itsFARAPULSE Pulsed Field Ablation (PFA) ProductReceived CE Approval for Market Launch, becomingThe World's First PFA Technology to Receive CE Approval, used for ablation in the field of atrial fibrillation, can be said to be the big brother in the PFA field.

Until November 2023, Medtronic announced that its PFA product, PulseSelect, had received CE approval for market release.

Boston Scientific was expected to simply wait steadily for the FDA certification. However, no one anticipated that in less than a month,MedtronicAnnounced again, announcing itsPulseSelect Pulsed Field Ablation SystemReceived FDA approval for marketing, becomingThe World's First PFA Product to Receive FDA Approval。

Medtronic's approval announcement even preceded the FDA's official database, which means that in this FDA approval race, it has outpaced Boston Scientific. At this point, Medtronic has already launched two PFA products in the atrial fibrillation field.

A key factor in Medtronic's ability to stand out among many competitors and launch the world's first FDA-approved PFA product isIDE Research Data Shows Excellent Performance, far exceeding expectations.According to the IDE study data published by Medtronic at the beginning of the year,PulseSelect surpassed the expected goals in terms of safety and effectiveness (the rate of safety events for patients with paroxysmal and persistent AF was 0.7%,Clinical success rate was 80%）。

On January 8, 2024, the third major player in the PFA fieldJohnson & JohnsonAlso unwilling to lag behind, announcing itsFirst PFA Product---VARIPULSEApproved for marketing by Japan's Ministry of Health, Labour and Welfare (MHLW), applicable for the treatment of symptomatic drug-refractory recurrent paroxysmal atrial fibrillation. This isJapan's First Approved PFA Product.

Compared with Medtronic and Boston Scientific,Johnson & Johnson'sStepAdjustAlthoughSlower, but looking at this piecePFA Market Worth $9 Billion with Only About 5% Penetration, Still Growing at a Double-Digit RateStill thrilled by nature.

Until January 31, 2024,Boston ScientificThe company has just announced itsFARAPULSE Pulsed Field Ablation System Receives FDA Approval for Market Launch, for the treatment of refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

What the future holds for the PFA market remains uncertain, with numerous strong competitors vying for this highly coveted opportunity. Ultimately, however, we look forward to manufacturers both in China and overseas showcasing their unique strengths through healthy competition, driving innovation, and delivering better treatment and care experiences for patients!

About Boston Scientific‍‍

Boston Scientific (NYSE: BSX) was founded in 1979 and is headquartered in Natick, Massachusetts, USA. It is a global leading medical technology company.

In 1997, Boston Scientific entered China, establishing branch offices and R&D centers in Beijing, Shanghai, and Guangzhou. The company's headquarters in China is located in Shanghai. In May 1992, Boston Scientific was successfully listed on the New York Stock Exchange.

The company has more than 17,000 products that improve the quality of life.Covering fields such as cardiac intervention, structural heart disease, peripheral and tumor intervention, cardiac rhythm management and electrophysiology, endoscopic intervention, respiratory intervention, urology, otorhinolaryngology, and neuromodulation.。

From 2004 to 2020, Boston Scientific was consistently ranked among the Fortune 500 companies; from 2016 to 2021, Boston Scientific was named one of the World's Most Admired Companies by Fortune for six consecutive years.

From 2017 to 2021, it ranked on the "Global Top 100 Innovators" list selected by Clarivate Analytics (formerly Thomson Reuters) for five consecutive years.

From 2013 to present, Boston Scientific has had a total of nine products or technologies win or be nominated for the Prix Galien Award, including three products nominated for the 2022 Prix Galien "Best Medical Technology" award, making it the company with the most nominations in that category for the year.

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