First Clinical Results from MAGiC Catheter Study Published in the Journal of Interventional Cardiac Electrophysiology
Stereotaxis (NYSE: STXS), a pioneer in surgical robotics, announced the publication of first clinical results for its MAGiC catheter in the Journal of Interventional Cardiac Electrophysiology. The prospective multi-center study demonstrated an impressive 94% acute efficacy rate in treating various heart arrhythmias.
The study, conducted at Copenhagen University Hospital Rigshospitalet and Vilnius University Hospital Santaros Klinikos, included 67 patients with various arrhythmias. The average procedure time was 83 minutes skin-to-skin, with a low procedure-related adverse event rate of 1.5%. Patient enrollment continues with approximately 100 patients enrolled to date, with efficacy assessments ongoing for up to one year.
The MAGiC catheter, designed for robotically-navigated magnetic ablation procedures, showed notable improvements in stability, eliminating the need for sheaths for catheter support. The technology has already been utilized in treating over 150,000 patients across leading hospitals globally.
Stereotaxis (NYSE: STXS), pioniere nella robotica chirurgica, ha annunciato la pubblicazione dei primi risultati clinici per il suo catetere MAGiC sulla rivista Journal of Interventional Cardiac Electrophysiology. Lo studio prospettico multicentrico ha mostrato un impressionante tasso di efficacia acuta del 94% nel trattamento di varie aritmie cardiache.
Lo studio, condotto presso l'Ospedale Universitario Rigshospitalet di Copenaghen e l'Ospedale Universitario Santaros Klinikos di Vilnius, ha coinvolto 67 pazienti con diverse aritmie. Il tempo medio della procedura è stato di 83 minuti dalla prima incisione alla chiusura, con un basso tasso di eventi avversi correlati alla procedura pari a 1,5%. L'arruolamento dei pazienti continua, con circa 100 pazienti iscritti finora e valutazioni di efficacia in corso fino a un anno.
Il catetere MAGiC, progettato per procedure di ablazione magnetica guidate roboticamente, ha mostrato miglioramenti significativi nella stabilità, eliminando la necessità di guaine per il supporto del catetere. La tecnologia è già stata utilizzata nel trattamento di oltre 150.000 pazienti in ospedali di rilievo a livello mondiale.
Stereotaxis (NYSE: STXS), pionero en robótica quirúrgica, anunció la publicación de los primeros resultados clínicos de su catéter MAGiC en la revista Journal of Interventional Cardiac Electrophysiology. El estudio prospectivo multicéntrico demostró una impresionante tasa de eficacia aguda del 94% en el tratamiento de diversas arritmias cardíacas.
El estudio, realizado en el Hospital Universitario Rigshospitalet de Copenhague y en el Hospital Universitario Santaros Klinikos de Vilnius, incluyó a 67 pacientes con diferentes arritmias. El tiempo promedio del procedimiento fue de 83 minutos de piel a piel, con una baja tasa de eventos adversos relacionados con el procedimiento del 1,5%. La inscripción de pacientes continúa, con aproximadamente 100 pacientes inscritos hasta la fecha y evaluaciones de eficacia en curso hasta por un año.
El catéter MAGiC, diseñado para procedimientos de ablación magnética guiados por robot, mostró mejoras notables en la estabilidad, eliminando la necesidad de fundas para el soporte del catéter. La tecnología ya se ha utilizado para tratar a más de 150,000 pacientes en hospitales líderes a nivel mundial.
Stereotaxis (NYSE: STXS), 수술용 로봇 분야의 선구자인 이 회사는 MAGiC 카테터의 첫 임상 결과를 Journal of Interventional Cardiac Electrophysiology에 발표했다고 밝혔다. 전향적 다기관 연구에서 다양한 심장 부정맥 치료에 있어 94%의 급성 효능률을 입증했다.
이 연구는 코펜하겐 대학 병원 Rigshospitalet와 빌뉴스 대학 병원 Santaros Klinikos에서 수행되었으며, 다양한 부정맥을 가진 67명의 환자가 포함되었다. 평균 시술 시간은 83분으로 피부 절개부터 마감까지이며, 시술 관련 부작용 발생률은 1.5%로 낮았다. 환자 등록은 계속 진행 중이며 현재까지 약 100명의 환자가 등록되었고, 효능 평가는 최대 1년까지 진행 중이다.
로봇 내비게이션 방식의 자기 절제 시술용으로 설계된 MAGiC 카테터는 안정성에서 눈에 띄는 개선을 보였으며, 카테터 지지용 셰스(도관)가 필요 없어졌다. 이 기술은 전 세계 주요 병원에서 이미 15만 명 이상의 환자 치료에 사용되고 있다.
Stereotaxis (NYSE : STXS), pionnier en robotique chirurgicale, a annoncé la publication des premiers résultats cliniques de son cathéter MAGiC dans le Journal of Interventional Cardiac Electrophysiology. L'étude prospective multicentrique a démontré un taux d'efficacité aiguë de 94% dans le traitement de diverses arythmies cardiaques.
L'étude, menée à l'Hôpital universitaire Rigshospitalet de Copenhague et à l'Hôpital universitaire Santaros Klinikos de Vilnius, a inclus 67 patients présentant différentes arythmies. La durée moyenne de la procédure était de 83 minutes de la première incision à la fermeture, avec un faible taux d'événements indésirables liés à la procédure de 1,5%. Le recrutement des patients se poursuit, avec environ 100 patients inclus à ce jour, et des évaluations d'efficacité en cours jusqu'à un an.
Le cathéter MAGiC, conçu pour des procédures d'ablation magnétique robotisée, a montré des améliorations notables en termes de stabilité, éliminant le besoin de gaines pour le soutien du cathéter. Cette technologie a déjà été utilisée pour traiter plus de 150 000 patients dans des hôpitaux de premier plan à travers le monde.
Stereotaxis (NYSE: STXS), ein Vorreiter in der chirurgischen Robotik, gab die Veröffentlichung der ersten klinischen Ergebnisse für seinen MAGiC-Katheter im Journal of Interventional Cardiac Electrophysiology bekannt. Die prospektive multizentrische Studie zeigte eine beeindruckende 94%ige akute Wirksamkeitsrate bei der Behandlung verschiedener Herzrhythmusstörungen.
Die Studie, durchgeführt am Universitätsklinikum Rigshospitalet in Kopenhagen und am Universitätsklinikum Santaros Klinikos in Vilnius, umfasste 67 Patienten mit unterschiedlichen Arrhythmien. Die durchschnittliche Prozedurdauer betrug 83 Minuten von Hautschnitt bis Wundverschluss, mit einer niedrigen prozedurbezogenen Komplikationsrate von 1,5%. Die Patientenaufnahme läuft weiter, bisher wurden etwa 100 Patienten eingeschlossen, und die Wirksamkeitsbewertung erfolgt bis zu einem Jahr.
Der MAGiC-Katheter, entwickelt für robotergestützte magnetische Ablationsverfahren, zeigte deutliche Verbesserungen in der Stabilität und eliminierte die Notwendigkeit von Führungsrohren zur Katheterunterstützung. Die Technologie wurde bereits bei über 150.000 Patienten in führenden Krankenhäusern weltweit eingesetzt.
- Strong 94% acute efficacy rate in clinical trials
- Low 1.5% procedure-related adverse event rate
- Improved catheter stability reported by experienced physicians
- Lower irrigation rates beneficial for patients with poor cardiac and renal function
- Successful treatment across broad spectrum of arrhythmias in all four heart chambers
- Technology already implemented in over 100 leading hospitals globally
- Study limited to initial analysis of 67 patients
- Long-term efficacy data still pending for up to one year
- Adverse events noted in high-risk patients, though within expected range
Insights
Stereotaxis's MAGiC catheter shows impressive 94% acute efficacy with strong safety profile, supporting European commercialization of this innovative robotic ablation technology.
The peer-reviewed publication of the MAGiC catheter's first clinical results represents a significant milestone for Stereotaxis. The prospective multi-center study demonstrated 94% acute efficacy across a diverse range of arrhythmias affecting all four heart chambers, comparing favorably to existing ablation technologies. The 1.5% adverse event rate aligns with known risks of radiofrequency ablation procedures rather than device malfunctions.
What's particularly noteworthy is the catheter's performance characteristics. Experienced electrophysiologists with extensive robotic procedure history specifically highlighted MAGiC's improved stability, eliminating the need for supportive sheaths. The catheter maintained steady tip temperatures during ablation while requiring lower irrigation rates – a meaningful benefit for patients with compromised cardiac and renal function.
The 83-minute average procedure time suggests efficient workflow integration. While this initial analysis focuses on acute outcomes from 67 patients, the ongoing enrollment (approximately 100 patients to date) with follow-up assessments extending to one year will provide crucial long-term efficacy data.
From a technological perspective, MAGiC builds upon Stereotaxis's substantial installed base at over 100 leading hospitals globally with 150,000+ patients already treated using their robotic platforms. This catheter appears to advance their value proposition in the cardiac electrophysiology space by enhancing precision while maintaining the safety advantages of a soft, flexible catheter design.
ST. LOUIS, July 01, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the publication of initial clinical results using the MAGiC catheter in the Journal of Interventional Cardiac Electrophysiology. Titled “First In‑Human Results of the MAGiC Robotic Magnetic Navigation Radiofrequency Ablation Catheter,” the publication is the first peer-reviewed literature supporting the efficacy and safety of Stereotaxis’ MAGiC catheter.
“We are delighted to see the strong efficacy and safety profile of MAGiC published in a prestigious journal,” said David Fischel, Stereotaxis Chairman and CEO. “This publication supports our ongoing launch of MAGiC across Europe. We appreciate the pioneering electrophysiologists at Copenhagen University Hospital Rigshospitalet and Vilnius University Hospital Santaros Klinikos who made this possible.”
The prospective multi-center, single-arm study used MAGiC to treat patients with a broad spectrum of arrhythmia – atrioventricular nodal reentrant tachycardia, Wolf-Parkinson-White syndrome, atrial fibrillation, atrial flutter, premature ventricular contractions, and ventricular tachycardia – in all four chambers of the heart. The initial analysis of the study includes acute efficacy and safety for 67 patients. Patient enrollment is ongoing with approximately a hundred patients enrolled to date and continued assessments of sustained efficacy ongoing for up to one year.
Acute efficacy of MAGiC in this study was
The authors of the study, with combined experience treating over 6,500 robotic procedures with previously available magnetic catheters, noted the noticeably improved stability of MAGiC, not needing to use sheaths for catheter support and stability, steady catheter tip temperatures during ablation, low irrigation rates benefiting patients with poor cardiac and renal function, and the potential for more efficient and effective lesions.
Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The MAGiC catheter is designed to enhance treatment precision and control during cardiac ablation, while maintaining the intrinsic safety advantage of a soft flexible catheter. Stereotaxis’ robotic technologies are at the forefront of efforts to advance robotics in minimally-invasive endovascular surgeries. Its robots have already been used by physicians at over 100 leading hospitals globally to treat over 150,000 patients.
The publication can be found at https://link.springer.com/article/10.1007/s10840-025-02082-z. To access a complete database of more than 500 scientific publications referencing Stereotaxis technology, visit www.RoboticEP.com/clinical-data/publications-database/.
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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