Boston Scientific Initiates AVANT GUARD Clinical Trial to Evaluate FARAPULSE™ Pulsed Field Ablation System as First-Line Treatment for Persistent Atrial Fibrillation
- AVANT GUARD trial aims to change clinical practice by advancing the therapy for persistent AF
- FARAPULSE PFA System has demonstrated promising safety and effectiveness profile
- Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial
- Potential adverse effects and limited efficacy of anti-arrhythmic drug therapy for persistent AF patients
- Risk of recurrence of cardiac arrhythmias and adverse events related to the FARAPULSE PFA System
The initiation of the AVANT GUARD clinical trial by Boston Scientific to evaluate the FARAPULSE PFA System as a first-line treatment for persistent atrial fibrillation (AF) is a significant development in the treatment of cardiac arrhythmias. From a clinical perspective, the potential shift from anti-arrhythmic drug (AAD) therapy to Pulsed Field Ablation (PFA) could represent a paradigm shift in managing persistent AF, which is known for its challenging management and suboptimal response to AADs.
PFA is a relatively new technique that uses electric fields to ablate heart tissue without generating significant heat, which could minimize collateral damage to surrounding tissue. This trial's focus on comparing PFA to AADs directly addresses the current gap in first-line treatment efficacy and safety for persistent AF patients. If the FARAPULSE PFA System demonstrates superior outcomes, it could lead to a change in clinical guidelines and practice, favoring PFA over AADs for certain patient populations.
Moreover, the inclusion of the Boston Scientific LUX-Dx™ Insertable Cardiac Monitor in the trial design is noteworthy. The device's ability to provide continuous rhythm monitoring and automatically transmit arrhythmia data will enhance the accuracy of AF burden measurement, which is crucial for assessing the long-term effectiveness of the treatment modalities being compared.
Boston Scientific's advancement into the clinical trial phase for the FARAPULSE PFA System as a first-line treatment for persistent AF could have substantial implications for the company's market position. The trial's outcome could potentially expand the indications for the FARAPULSE PFA System, currently being evaluated for paroxysmal AF treatment, to include persistent AF as well.
From an industry standpoint, successful trial results could disrupt the current standard-of-care for persistent AF and position Boston Scientific as a leader in cardiac ablation technology. This could result in increased market share and revenue growth for the company, particularly if the FARAPULSE PFA System is approved by the FDA as anticipated in the first quarter of 2024.
Investors and stakeholders should monitor the progress and results of the AVANT GUARD trial closely, as positive outcomes may lead to an increase in the company's stock value due to the potential for expanded usage and increased sales of the FARAPULSE PFA System.
The strategic investment by Boston Scientific in the FARAPULSE PFA System's clinical trials underscores the company's commitment to innovation and market expansion within the cardiac care sector. The expected FDA approval in early 2024 could be a pivotal moment for the company's financial performance, particularly if the trial results favor the FARAPULSE PFA System over traditional AAD therapy.
As the trial involves more than 500 patients across up to 75 global sites, the scale of the study indicates a significant investment by Boston Scientific in both financial and operational terms. The trial's successful completion and positive results could justify this investment by paving the way for a potentially lucrative product line.
Investors should consider the risk associated with the clinical trial outcomes, as the company's stock could be influenced by the perceived efficacy and safety of the FARAPULSE PFA System compared to current treatment standards. The long-term financial implications hinge on the system's market adoption rate, which will depend on clinical outcomes, physician adoption, reimbursement scenarios and competitive dynamics in the cardiac ablation market.
Unlike paroxysmal AF, which describes symptoms that last for seven days or fewer, persistent AF is a sustained arrhythmia that lasts for more than a week1. Early treatment of persistent AF can reduce the risk of blood clots, stroke, and heart failure, and may prevent the disease from becoming permanent. Patients are often treated with AADs as frontline therapy for heart rhythm maintenance, though some can experience adverse effects and limited efficacy. Cardiac ablation is a potential alternative interventional strategy for those living with persistent AF.
"With nearly 40,000 patients treated to date in clinical and commercial settings, the FARAPULSE PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build," said Dr. Brad
The randomized AVANT GUARD trial will enroll more than 500 patients diagnosed with persistent AF at up to 75 sites globally. Patients in the study will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA System, or receive AAD treatment, and followed for three years. The trial will evaluate the outcomes of therapy provided with the FARAPULSE PFA System versus AADs, including device-or procedure-related adverse events, the rates of freedom from AF, atrial flutter, or atrial tachycardia, as well as AF burden – a measurement of the amount of AF an individual experiences.
All patients in the trial will also be inserted with the Boston Scientific LUX-Dx™ Insertable Cardiac Monitor. This device simplifies the monitoring process for patients by automatically capturing and transmitting arrhythmia episode data, and is designed to detect recurrence of cardiac arrhythmias and assess AF burden by providing continuous rhythm monitoring.
This week, the Cleveland Clinic enrolled the first patient in the AVANT GUARD trial, overseen by Dr. Oussama Wazni, vice chair of cardiovascular medicine and section head, Cardiac Electrophysiology and Pacing, Cleveland Clinic, who is also serving as the lead investigator of the trial.
Earlier this year, clinical trial data presented demonstrated the FARAPULSE PFA System is noninferior to standard-of-care therapies for the treatment of paroxysmal AF, with superior efficiency, while additional real-world data from more than 17,000 patients demonstrated continued real-world safety, efficacy and efficiency of the system. Boston Scientific also completed enrollment in the first phase of the ADVANTAGE AF clinical trial in the third quarter of 2023, which is studying the system for the treatment of patients with drug refractory symptomatic persistent AF, and commenced enrollment in an extension arm of the study to evaluate the safety and effectiveness of adjunctive use of the FARAPOINT™ PFA Catheter for cavotricuspid isthmus (CTI) ablations, a procedure used to treat atrial flutter.
The company now anticipates
*Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, and product performance and impact, new and anticipated product approvals and launches, and clinical trials. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
CONTACTS:
Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
1 https://doi.org/10.1161/CIR.0000000000001193. Circulation. 2023;0
View original content to download multimedia:https://www.prnewswire.com/news-releases/boston-scientific-initiates-avant-guard-clinical-trial-to-evaluate-farapulse-pulsed-field-ablation-system-as-first-line-treatment-for-persistent-atrial-fibrillation-302023445.html
SOURCE Boston Scientific Corporation
