Boston Scientific Launches Next Generation of Cardiac Mapping for the FARAPULSE™ Pulsed Field Ablation System
Boston Scientific (NYSE: BSX) has received FDA approval for the FARAWAVE™ NAV Ablation Catheter and FDA 510(k) clearance for the FARAVIEW™ Software. These technologies enhance the FARAPULSE™ Pulsed Field Ablation (PFA) System for treating paroxysmal atrial fibrillation (AF).
The FARAWAVE NAV Ablation Catheter adds magnetic navigation capabilities, allowing cardiac mapping and PFA therapy delivery in a single integrated catheter. The FARAVIEW Software provides visualization for cardiac ablation procedures, offering a dynamic view of catheter placement, shape, and rotation.
These advancements are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures. The FARAPULSE PFA System has been used to treat over 125,000 patients globally. Boston Scientific will immediately launch these new technologies in the U.S.
Boston Scientific (NYSE: BSX) ha ricevuto l'
Il catetere di ablazione FARAWAVE NAV aggiunge capacità di navigazione magnetica, consentendo la mappatura cardiaca e la somministrazione della terapia PFA in un singolo catetere integrato. Il software FARAVIEW offre visualizzazione per le procedure di ablazione cardiaca, fornendo una visione dinamica della posizione del catetere, della sua forma e rotazione.
Questi avanzamenti sono progettati per aumentare la fiducia nella somministrazione della terapia e semplificare i flussi di lavoro mappati durante le procedure PFA. Il sistema PFA FARAPULSE è stato utilizzato per trattare oltre 125.000 pazienti a livello globale. Boston Scientific lancerà immediatamente queste nuove tecnologie negli Stati Uniti.
Boston Scientific (NYSE: BSX) ha recibido la aprobación de la FDA para el catéter de ablación FARAWAVE™ NAV y la autorización 510(k) de la FDA para el software FARAVIEW™. Estas tecnologías mejoran el Sistema de Ablación de Campo Pulsado (PFA) FARAPULSE™ para el tratamiento de la fibrilación auricular paroxística (AF).
El catéter de ablación FARAWAVE NAV agrega capacidades de navegación magnética, permitiendo la mapeo cardíaco y la entrega de terapia PFA en un único catéter integrado. El software FARAVIEW proporciona visualización para los procedimientos de ablación cardíaca, ofreciendo una vista dinámica de la colocación, forma y rotación del catéter.
Estos avances están diseñados para aumentar la confianza en la entrega de terapia y simplificar los flujos de trabajo mapeados durante los procedimientos PFA. El sistema PFA FARAPULSE ha sido utilizado para tratar a más de 125,000 pacientes en todo el mundo. Boston Scientific lanzará de inmediato estas nuevas tecnologías en EE.UU.
보스턴 사이언티픽 (NYSE: BSX)은 FDA 승인을 받은 FARAWAVE™ NAV 절제 카테터와 FARAVIEW™ 소프트웨어에 대한 FDA 510(k) 승인을 받았습니다. 이러한 기술은 발작성 심방세동 (AF) 치료를 위한 FARAPULSE™ 펄스 필드 절제 (PFA) 시스템을 향상시킵니다.
FARAWAVE NAV 절제 카테터는 자기 내비게이션 기능을 추가하여 심장 맵핑 및 PFA 치료를 단일 통합 카테터로 제공합니다. FARAVIEW 소프트웨어는 심장 절제 절차를 위한 시각화를 제공하여 카테터의 위치, 형태 및 회전을 동적으로 볼 수 있게 합니다.
이러한 발전은 치료 제공에 대한 신뢰를 높이고 기록된 작업 흐름을 단순화하기 위해 설계되었습니다. FARAPULSE PFA 시스템은 전 세계적으로 125,000명 이상의 환자를 치료하는 데 사용되었습니다. 보스턴 사이언티픽은 이러한 새로운 기술을 즉시 미국에서 출시할 예정입니다.
Boston Scientific (NYSE: BSX) a obtenu l'approbation de la FDA pour le cathéter d'ablation FARAWAVE™ NAV et l'
Le cathéter d'ablation FARAWAVE NAV ajoute des capacités de navigation magnétique, permettant la cartographie cardiaque et l'administration de la thérapie PFA dans un cathéter intégré unique. Le logiciel FARAVIEW fournit une visualisation pour les procédures d'ablation cardiaque, offrant une vue dynamique de la position, de la forme et de la rotation du cathéter.
Ces avancées sont conçues pour augmenter la confiance dans l'administration de la thérapie et simplifier les flux de travail cartographiés lors des procédures PFA. Le système PFA FARAPULSE a été utilisé pour traiter plus de 125 000 patients dans le monde. Boston Scientific lancera immédiatement ces nouvelles technologies aux États-Unis.
Boston Scientific (NYSE: BSX) hat die FDA-Zulassung für den FARAWAVE™ NAV Ablation Catheter sowie die FDA 510(k) Genehmigung für die FARAVIEW™ Software erhalten. Diese Technologien verbessern das FARAPULSE™ Pulsed Field Ablation (PFA) System zur Behandlung der paroxysmalen Vorhofflimmern (AF).
Der FARAWAVE NAV Ablation Catheter bietet magnetische Navigationsfähigkeiten, sodass eine kardiale Mappung und die Verabreichung der PFA-Therapie in einem einzigen integrierten Katheter möglich sind. Die FARAVIEW Software bietet eine Visualisierung für kardiale Ablationsverfahren und ermöglicht einen dynamischen Blick auf die Platzierung, Form und Drehung des Katheters.
Diese Fortschritte sind darauf ausgelegt, das Vertrauen in die Therapieabgabe zu erhöhen und die gemappten Arbeitsabläufe während der PFA-Verfahren zu vereinfachen. Das FARAPULSE PFA System wurde bereits zur Behandlung von über 125.000 Patienten weltweit eingesetzt. Boston Scientific plant, diese neuen Technologien umgehend in den USA einzuführen.
- FDA approval for FARAWAVE NAV Ablation Catheter and FDA 510(k) clearance for FARAVIEW Software
- Integration of cardiac mapping and PFA therapy delivery in a single catheter
- Enhanced visualization capabilities for cardiac ablation procedures
- Potential for increased efficiency and reduced need for device exchanges during procedures
- FARAPULSE PFA System has been used to treat over 125,000 patients globally
- None.
Insights
The launch of the FARAWAVE™ NAV Ablation Catheter and FARAVIEW™ Software represents a significant advancement in cardiac mapping and pulsed field ablation (PFA) technology. This integrated system offers several key benefits:
- Enhanced visualization during PFA procedures
- Magnetic navigation capabilities for precise catheter placement
- Integrated mapping and therapy delivery in a single catheter
- Potential for reduced procedure time and device exchanges
- Automated tagging for therapy tracking and planning
These innovations could lead to improved procedural efficiency and potentially better outcomes for patients with atrial fibrillation. The compatibility with Boston Scientific's existing mapping systems and the large patient base already treated with the FARAPULSE™ PFA System (over 125,000 globally) suggest a strong market position and potential for rapid adoption.
While the immediate impact on Boston Scientific's financials may be , this launch strengthens their competitive position in the growing electrophysiology market, particularly in the PFA segment. Long-term, it could drive market share gains and contribute to revenue growth in the company's rhythm management division.
This product launch is strategically significant for Boston Scientific (BSX) in the competitive electrophysiology market. Key financial implications include:
- Potential for increased market share in the atrial fibrillation treatment space
- Enhanced product differentiation, which could support premium pricing
- Possible acceleration of revenue growth in the rhythm management segment
- Opportunity for cross-selling within BSX's existing customer base
While specific revenue projections aren't provided, the immediate U.S. launch suggests near-term impact on sales. The large existing patient base (125,000+ treated globally) indicates a substantial market opportunity. Additionally, the potential for improved procedural efficiency could drive hospital adoption, supporting long-term growth.
Investors should monitor upcoming quarterly reports for indications of uptake and impact on the rhythm management division's performance. This launch aligns with BSX's strategy of innovation-driven growth and could contribute to maintaining its strong position in the
New FARAWAVE™ NAV Ablation Catheter and FARAVIEW™ Software combine with OPAL HDx™ Mapping System to provide visualization during pulsed field ablation
Today, physicians may utilize a separate mapping catheter prior to a cardiac PFA procedure to examine and analyze the heart's electrical patterns and plan the therapeutic applications for each patient. The FARAWAVE NAV Ablation Catheter builds upon the current FARAWAVE catheter by adding magnetic navigation capabilities, enabling cardiac mapping and PFA therapy delivery within a single integrated catheter, while minimizing the need for additional device exchanges. Mapped procedures with the FARAPULSE PFA System are visually depicted for physicians via the FARAVIEW Software, which offers a dynamic view of catheter placement, shape and rotation.
"The addition of the FARAWAVE NAV Ablation Catheter and FARAVIEW Software to our portfolio provides a next-level pulsed field ablation mapping experience with cost-effective tools developed specifically and uniquely for the FARAPULSE PFA System," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. "Built on this safe and clinically-proven platform – which has been used to treat more than 125,000 patients globally – the visualization capabilities offered by these new technologies are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures."
The latest advancement within the Boston Scientific PFA portfolio, the FARAVIEW Software magnetically tracks the FARAWAVE NAV Ablation Catheter, which allows physicians to see where pulsed fields have been applied and visualize cumulative therapy delivery to guide ablation strategy. Delivery of PFA with the FARAWAVE NAV Ablation Catheter can be tracked through automated tagging technology, which is intended to assist physicians in planning, executing and confirming application of therapy by showing the approximate pulsed field locations within the heart, based on the catheter's position.
"In clinical use, the FARAVIEW Software and FARAWAVE NAV Ablation Catheter produced detailed cardiac maps that could improve guidance, limit fluoroscopy times and assist physicians in assessing the location of energy delivered during PFA procedures," said Vivek Reddy, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital,
Boston Scientific will immediately launch the FARAWAVE NAV Ablation Catheter and FARAVIEW Software in the
*Dr. Vivek Reddy is a paid consultant of 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 45 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. 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 X, formerly Twitter.
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FAQ
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