First US Commercial Robotic HD Mapping Procedures Successfully Completed with MAGiC Sweep Catheter
Stereotaxis (NYSE: STXS) has achieved a significant milestone with the completion of the world's first procedures using MAGiC Sweep™, their pioneering robotically-navigated high-density electrophysiology mapping catheter. The procedures were successfully performed at Deborah Heart and Lung Center in New Jersey.
The MAGiC Sweep catheter demonstrated key advantages including accurate mapping of complex anatomy, stable cardiac tissue contact, clear electrogram signals, and absence of ventricular ectopy. Following recent FDA clearance, Stereotaxis has begun the commercial launch in the United States, while European regulatory clearance is pending.
This breakthrough represents a major advancement in robotic electrophysiology, with the technology already used to treat over 150,000 patients globally across the United States, Europe, and Asia.
Stereotaxis (NYSE: STXS) ha raggiunto un traguardo importante completando le prime procedure al mondo con MAGiC Sweep™, il suo catetere di mappatura elettrofisiologica ad alta densità navigato roboticamente. Le procedure sono state eseguite con successo al Deborah Heart and Lung Center nel New Jersey.
Il catetere MAGiC Sweep ha dimostrato vantaggi chiave come la mappatura accurata di anatomie complesse, un contatto stabile con il tessuto cardiaco, segnali elettrogramma nitidi e l’assenza di ectopie ventricolari. Dopo la recente autorizzazione FDA, Stereotaxis ha avviato il lancio commerciale negli Stati Uniti; è in attesa dell’approvazione normativa in Europa.
Questa innovazione segna un passo avanti rilevante nell’elettrofisiologia robotica: la tecnologia è già stata impiegata per curare oltre 150.000 pazienti a livello globale in Stati Uniti, Europa e Asia.
Stereotaxis (NYSE: STXS) ha alcanzado un hito importante al completar los primeros procedimientos en el mundo con MAGiC Sweep™, su catéter de mapeo electrofisiológico de alta densidad guiado por robot. Los procedimientos se llevaron a cabo con éxito en el Deborah Heart and Lung Center de Nueva Jersey.
El catéter MAGiC Sweep mostró ventajas clave como el mapeo preciso de anatomías complejas, contacto estable con el tejido cardíaco, señales electrograma claras y ausencia de ectopia ventricular. Tras la reciente autorización de la FDA, Stereotaxis ha iniciado el lanzamiento comercial en Estados Unidos, mientras que la aprobación regulatoria en Europa está pendiente.
Este avance representa un progreso importante en la electrofisiología robótica, y la tecnología ya se ha utilizado para tratar a más de 150.000 pacientes en todo el mundo en Estados Unidos, Europa y Asia.
Stereotaxis (NYSE: STXS)는 로봇 유도 고밀도 전기생리학 매핑 카테터인 MAGiC Sweep™를 이용한 세계 최초의 시술을 성공적으로 완료하는 중요한 이정표를 달성했습니다. 해당 시술은 뉴저지의 Deborah Heart and Lung Center에서 성공적으로 시행되었습니다.
MAGiC Sweep 카테터는 복잡한 해부 구조의 정확한 매핑, 안정적인 심장 조직 접촉, 선명한 심전도 신호, 그리고 심실성 이소성 박동의 부재 등 주요 장점을 입증했습니다. 최근 FDA 허가를 받은 뒤 Stereotaxis는 미국 내 상업 출시를 시작했으며, 유럽 규제 승인은 현재 진행 중입니다.
이 혁신은 로봇 전기생리학 분야의 중요한 진전으로, 해당 기술은 이미 미국, 유럽, 아시아 전역에서 150,000명 이상의 환자 치료에 사용되었습니다.
Stereotaxis (NYSE: STXS) a franchi une étape majeure en réalisant les premières procédures au monde avec MAGiC Sweep™, son cathéter de cartographie électrophysiologique haute densité guidé robotiquement. Les interventions ont été réalisées avec succès au Deborah Heart and Lung Center dans le New Jersey.
Le cathéter MAGiC Sweep a montré des avantages clés tels qu’une cartographie précise d’anatomies complexes, un contact tissulaire cardiaque stable, des signaux électrogrammes nets et l’absence d’extrasystoles ventriculaires. Après la récente autorisation de la FDA, Stereotaxis a lancé la commercialisation aux États-Unis, tandis que l’autorisation en Europe est en attente.
Cette avancée représente un progrès significatif en électrophysiologie robotique ; la technologie a déjà été utilisée pour traiter plus de 150 000 patients dans le monde, aux États-Unis, en Europe et en Asie.
Stereotaxis (NYSE: STXS) hat einen wichtigen Meilenstein erreicht: die Durchführung der weltweit ersten Eingriffe mit MAGiC Sweep™, seinem robotergestützten, hochdichten Katheter zur elektrophysiologischen Kartierung. Die Eingriffe wurden erfolgreich im Deborah Heart and Lung Center in New Jersey durchgeführt.
Der MAGiC Sweep-Katheter zeigte wesentliche Vorteile wie die präzise Kartierung komplexer Anatomien, stabilen Kontakt zum Herzgewebe, klare Elektrogrammsignale und das Fehlen ventrikulärer Ektopien. Nach der jüngsten FDA-Freigabe hat Stereotaxis den kommerziellen Start in den USA begonnen; die Zulassung in Europa steht noch aus.
Dieser Durchbruch stellt einen bedeutenden Fortschritt in der robotischen Elektrophysiologie dar und die Technologie wurde bereits bei über 150.000 Patienten weltweit in den USA, Europa und Asien eingesetzt.
- First-to-market with robotically-navigated high-density EP mapping catheter
- Successful commercial launch initiated following FDA clearance
- Technology demonstrates superior mapping accuracy and tissue contact stability
- Established track record with over 150,000 patients treated globally
- European market expansion potential with pending regulatory clearance
- Success dependent on regulatory approval in European market
- Revenue recognition subject to contingencies outside company control
- Potential competitive and economic market risks acknowledged in forward-looking statements
Insights
Stereotaxis completes first commercial procedures with innovative MAGiC Sweep catheter, marking significant advancement in robotic cardiac mapping technology.
Stereotaxis has achieved a notable milestone with the first successful commercial procedures using its MAGiC Sweep™ catheter – the world's first robotically-navigated high-density electrophysiology mapping device. This breakthrough occurred at Deborah Heart and Lung Center in New Jersey, following recent FDA clearance.
The clinical significance is substantial. High-density mapping creates detailed cardiac electrical activity maps essential for precisely diagnosing and treating arrhythmias. The physicians involved reported several distinct advantages: easy navigation to desired cardiac locations, stable tissue contact, clear electrogram signals, and notably, no ventricular ectopy (unwanted heart rhythm disturbances during catheter manipulation).
This technology represents a meaningful advancement in the
For Stereotaxis, whose robotic technology has already been used in over 150,000 patients globally, this commercial launch could accelerate adoption of their robotic platforms by offering electrophysiologists a more comprehensive toolset for cardiac procedures. The technology potentially improves procedural outcomes while maintaining the safety benefits of robotic precision in the interventional laboratory.
ST. LOUIS, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the successful completion of the world’s first procedures using MAGiC Sweep™, the first and only robotically-navigated high-density electrophysiology (EP) mapping catheter. The procedures were performed by Dr. Raffaele Corbisiero and Dr. Pedram Kazemian at Deborah Heart and Lung Center in Browns Mills, New Jersey.
“We’re excited to be the first to demonstrate the value of robotic high-density mapping and to offer this important innovation to our patients,” said Dr. Corbisiero, Chief of Electrophysiology at Deborah Heart and Lung Center. “The ability to create a more accurate, detailed map of complex anatomy is important in diagnosing and treating arrhythmias. We have been impressed with the catheter during our experience mapping several different arrhythmias in the atria and ventricles.”
“Navigating MAGiC Sweep to any desired cardiac location was easy, the catheter maintained stable contact with cardiac tissue, electrogram signals were very clear, and the catheter caused no ectopy in the ventricle,” added Dr. Kazemian, Program Director of EP Fellowship at Deborah Heart and Lung Center. “This is a significant leap forward for the community of robotic electrophysiologists and we look forward to the positive impact its expanded use will have on our patients and the EP field.”
Stereotaxis has initiated commercial launch of MAGiC Sweep in the United States following recent FDA clearance of the catheter. MAGiC Sweep has been submitted for regulatory clearance in Europe.
About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe”, "estimate”, "project”, "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to manage expenses at sustainable levels, acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control and may be revised, modified, delayed, or canceled.
Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer
Kimberly Peery
Chief Financial Officer
314-678-6100
Investors@Stereotaxis.com
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