MARLBOROUGH, Mass., April 8, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX ) has initiated the NAVIGATE-PF study of the FARAVIEW™* software module when used to visualize and monitor the FARAWAVE™ Pulsed Field Ablation (PFA) Nav Catheter* for the treatment of patients with paroxysmal and persistent fibrillation atria (AF). FARAVIEW technology and the FARAWAVE Nav catheter extend the capabilities of the FARAPULSE™ PFA system through integration with our cardiac mapping system.
In the pulsed field cardiac ablation procedure, a catheter is guided into the heart to apply targeted non-thermal electrical fields that selectively treat heart tissue cells while avoiding damage to nearby structures. Before PFA therapy is administered, the physician may use a separate cardiac mapping catheter to view and analyze the heart’s electrical patterns in order to plan PFA administration. The FARAWAVE Nav PFA Catheter adds magnetic navigation capabilities to the current FARAWAVE PFA Catheter, enabling detailed mapping and PFA therapy within the same device. This mapping data is visualized using the new FARAVIEW software module, which offers a customized mapping solution for procedures with the FARAPULSE PFA system.
“Creating a detailed cardiac map during the ablation procedure can improve guidance, reduce fluoroscopy time, and help physicians estimate the location of the delivered energy, which can improve patient outcomes,” said Ignacio García-Bolao, MD, Ph.D., study investigator and director. of Cardiology and Cardiovascular Surgery, Clinica Universidad de Navarra, Pamplona, Spain. “Through this study, we hope to identify the procedural advantages of the FARAWAVE Nav Catheter, which can both map and ablate, with technology that enables magnetically tracked, dynamic visualization of the patient’s cardiac anatomy and catheter configuration.”
Approximately 30 patients in several European centers living with paroxysmal or persistent AF will be enrolled in the prospective, open-label, multicenter, single-arm NAVIGATE-PF study. All patients in the study will have cardiac mapping done during their procedures. Those living with paroxysmal AF will undergo pulmonary vein isolation, while patients with persistent AF will undergo additional posterior wall isolation at the discretion of the physician performing the procedure.
“This study seeks to build on the compelling performance of the FARAPULSE PFA system by providing an integrated mapping and navigation experience for physicians,” he said. Brad Sutton, MD, Chief Medical Officer, AF Solutions, Boston Scientific. “Adding navigation and visualization capabilities to this PFA system, which is leading the way in terms of safety, effectiveness and efficiency, is an exciting proposition for physicians and patients.”
Boston Scientific anticipates US regulatory approval for the FARAWAVE NAV PFA catheter and FARAVIEW software module in the second half of 2024.
More information about the FARAPULSE PFA system is available here.
*Caution: test device. Restricted by federal (or US) law to research use only. Not available for sale.
** Dr. Ignacio Garcia-Bolao is a paid consultant for Boston Scientific Corporation. He has not been compensated in connection with this press release.
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we’ve advanced science for life by providing a wide range of high-performance solutions that address unmet patient needs and reduce healthcare costs. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and xformerly Twitter.
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 such as “anticipate,” “expect”, “project”, “believe”, “plan”, “estimate”, “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information currently available to us 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, and new and anticipated product approvals and launches. If our underlying assumptions prove incorrect or if certain risks or uncertainties materialize, actual results may differ materially from the expectations and projections expressed or implied in our forward-looking statements. These factors have in some cases affected and may in the future (along with other factors) affect our ability to implement our business strategy and may cause actual results to differ materially from those anticipated by the statements made 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, but are not limited to: future economic, competitive, compensation and regulatory conditions; disruptions in the production, distribution and supply chain and cost increases; presentation of new products; demographic trends; intellectual property; lawsuit; 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 the Quarterly Reports on Form 10-Q that we have filed or will file below. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in the events, conditions or circumstances on which those expectations may be based or which may affect the likelihood that they will actual results may differ from those contained in the forward-looking statements. This cautionary statement applies to all forward-looking statements contained in this document.
CONTACTS:
Steve Bailey
Relations with the media
(651) 582-4343 (office)
[email protected]
Jon Monson
investor relations
(508) 683-5450
[email protected]
SOURCE Boston Scientific Corporation
