Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System for Treatment of Paroxysmal Atrial Fibrillation

Marlborough, Massachusetts, USA, February 2, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX)On January 31Boston Scientific Corporation announced that its FARAPULSE™ Pulsed Field Ablation System (PFA)* has received approval from the U.S. Food and Drug Administration (FDA). The FARAPULSE PFA System can treat drug-refractory, recurrent symptomatic paroxysmal atrial fibrillation through pulmonary vein isolation, serving as a novel alternative to traditional thermal ablation therapy.

Nick Spadea-Anello, President of Boston Scientific's Electrophysiology Division, stated: "The approval of the FARAPULSE PFA System is an important milestone for millions of patients with paroxysmal atrial fibrillation. The system has already set a new benchmark with its outstanding performance in clinical studies and commercial applications. To date, more than 40,000 patients have been treated with the FARAPULSE PFA System, and we look forward to this exceptional technology continuing to lead the development of the PFA field."

Traditional ablation delivers current through a catheter to cardiac tissue, destroying targeted areas associated with abnormal heart rhythms via heat conduction. In contrast, the PFA system employs a non-thermal therapy, selectively ablating cardiac tissue using an electric field while avoiding damage to adjacent structures. Positive 12-month results from the pivotal ADVENT study (the first randomized controlled trial directly comparing the efficacy and safety of the FARAPULSE PFA System with traditional thermal ablation) demonstrated that the FARAPULSE PFA System is non-inferior in safety and efficacy compared to traditional thermal ablation, with significantly reduced ablation times and physician learning curves. Additionally, real-world data from over 17,000 patients in the MANIFEST-17K registry confirmed the stable safety profile of the system, with no reports of persistent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury.

Dr. Vivek Reddy, an electrophysiology expert at Mount Sinai Hospital in New York, USA, stated: "The results of the ADVENT clinical trial show that the FARAPULSE PFA System is an efficient treatment for paroxysmal atrial fibrillation, consistent with a large amount of global real-world application data. The FARAPULSE PFA System offers high tissue selectivity and long-lasting effectiveness, significantly reducing procedure time and the learning curve. For doctors and patients in the United States, this system is highly likely to become a technology that transforms current clinical practice."

FARAPULSE PFA provides pulsed energy fields and consists of the FARAWAVE™ ablation catheter, FARASTAR™ ablation generator, and FARADRIVE™ steerable sheath. Among these, the FARADRIVE™ steerable sheath is used in conjunction with the VersaCross Connect™ Access solution to provide left atrial access during procedures. The FARAWAVE catheter can be used for various pulmonary vein anatomies, with the balloon-expandable catheter tip transforming into either a basket or flower-petal shape, allowing the device to adapt well to individual patient pulmonary vein morphology. These components enhance ease of use for physicians and improve procedural reproducibility.

Boston Scientific completed the enrollment for the first phase of the ADVANTAGE AF clinical trial in the third quarter of 2023 to study the efficacy of the PFA system in treating patients with drug-refractory symptomatic persistent atrial fibrillation; at the same time, Boston Scientific has initiated the second phase of this study to evaluate the safety and effectiveness of using the FARAPOINT™ PFA catheter as an adjunct for cavotricuspid isthmus (CTI) ablation in treating atrial fibrillation. Boston Scientific has also recently launched the AVANT GUARD clinical trial to assess the safety and efficacy of the FARAPULSE PFA system as a first-line treatment for persistent atrial fibrillation compared to antiarrhythmic drug therapy.

The FARAPULSE PFA System received the "Breakthrough Device Designation" from the U.S. FDA Center for Devices and Radiological Health (CDRH) in 2019, and obtained CE Mark approval in 2021. Boston Scientific plans to immediately initiate the system’s commercial launch in the United States. The company is currently developing the navigational version of the FARAWAVE catheter and the FARAVIEW™ software module, with anticipated U.S. regulatory approval expected by 2024.

*This product has not yet been launched in mainland China.

Translation for reference only, original text link can be accessed by clickingRead the original textView.

About Boston Scientific

Boston Scientific Corporation is committed to innovation for life. We are dedicated to innovative medical solutions that improve the lives of patients worldwide. For more than four decades, Boston Scientific has been at the forefront of the global medical technology industry, offering a wide range of high-performance medical solutions to meet critical patient needs and reduce healthcare costs. Boston Scientific's medical devices and related therapies assist doctors in diagnosing and treating complex diseases of the cardiovascular, respiratory, digestive, oncological, neurological, and urological systems.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 in the United States. Forward-looking statements can be identified by words such as "anticipate," "expect," "forecast," "believe," "plan," "estimate," "intend," and similar terms. These forward-looking statements are based on our views, assumptions, and estimates derived from the information available to us at that time, and are not guarantees of future events or performance. These forward-looking statements include our statements regarding the financial and commercial impact of this transaction, our business plans, product performance, and related impacts. If our underlying assumptions prove incorrect, or if certain risks or uncertainties materialize, actual results may differ materially from the expectations and forecasts expressed or implied in our forward-looking statements. These factors have affected, and may continue to affect (in conjunction with other factors), our ability to execute our business strategies in some cases, and could cause actual results to differ significantly from the expected results outlined in this press release. Therefore, we caution readers not to place undue reliance on any of our forward-looking statements.

Factors that may lead to such differences include: future economic conditions, competitive conditions, compensation and regulatory conditions; disruptions and increased costs in manufacturing, distribution, and supply chains; the introduction of new products; product performance; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions by us and our competitors. All of these factors are difficult or impossible to predict accurately, and we cannot control many of them. For a detailed list and description of significant risks and uncertainties that may affect our future business, please refer to Part I, Item 1A, "Risk Factors," in our latest Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission. This section may be updated in Part II, Item 1A, "Risk Factors," of our Quarterly Reports on Form 10-Q that have been or will be filed subsequently. We have no intention or obligation to publicly update or revise any forward-looking statements to reflect changes, whether due to a change in our expectations, or a change in the events, conditions, or circumstances on which those expectations are based, or other changes that could cause actual results to differ from those described in the forward-looking statements. This cautionary statement applies to all forward-looking statements in this document.