Stereotaxis Receives CE Mark Approval for the MAGiC Ablation Catheter
Stereotaxis (NYSE: STXS) has received European CE Mark approval for its MAGiC™ ablation catheter, designed for cardiac ablation procedures treating heart arrhythmia. The catheter was developed based on insights from nearly 20 years and 150,000 robotic ablation procedures using predecessor devices.
The MAGiC catheter features enhanced capabilities including optimized navigation with consistent contact forces, improved data collection through iConnect and eContact module integration, and efficient low-flow cooling that reduces patient fluid load. The device received broad European approval for creating local lesions in cardiac tissue to treat cardiac arrhythmias.
This approval follows extensive development, testing, manufacturing, and clinical research investments. Clinical studies in Europe support expectations for widespread adoption among robotic users.
Stereotaxis (NYSE: STXS) ha ricevuto l'approvazione del marchio CE europeo per il suo catetere di ablazione MAGiC™, progettato per procedure di ablazione cardiaca nel trattamento delle aritmie cardiache. Il catetere è stato sviluppato sulla base di quasi 20 anni di esperienza e 150.000 procedure di ablazione robotica utilizzando dispositivi precedenti.
Il catetere MAGiC presenta capacità avanzate tra cui navigazione ottimizzata con forze di contatto costanti, miglior raccolta dati tramite integrazione dei moduli iConnect ed eContact, e un efficiente raffreddamento a basso flusso che riduce il carico di fluidi sul paziente. Il dispositivo ha ricevuto un'ampia approvazione europea per la creazione di lesioni locali nei tessuti cardiaci per trattare le aritmie cardiache.
Questa approvazione segue investimenti considerevoli in sviluppo, test, produzione e ricerca clinica. Gli studi clinici in Europa supportano le aspettative per una diffusione ampia tra gli utenti robotici.
Stereotaxis (NYSE: STXS) ha recibido la aprobación del marcado CE europeo para su catéter de ablación MAGiC™, diseñado para procedimientos de ablación cardíaca que tratan la arritmia cardíaca. El catéter se desarrolló basándose en casi 20 años y 150,000 procedimientos de ablación robótica utilizando dispositivos anteriores.
El catéter MAGiC presenta capacidades mejoradas, incluyendo navegación optimizada con fuerzas de contacto consistentes, mejor recopilación de datos a través de la integración de los módulos iConnect y eContact, y un enfriamiento eficiente de bajo flujo que reduce la carga de fluidos en el paciente. El dispositivo recibió una amplia aprobación europea para crear lesiones locales en el tejido cardíaco para tratar las arritmias cardíacas.
Esta aprobación sigue a considerables inversiones en desarrollo, pruebas, fabricación e investigación clínica. Los estudios clínicos en Europa respaldan las expectativas de una adopción generalizada entre los usuarios robóticos.
스테레오택시스 (NYSE: STXS)는 심장 부정맥 치료를 위한 심장 절제 수술에 설계된 MAGiC™ 절제 카테터에 대해 유럽 CE 마크 승인을 받았습니다. 이 카테터는 거의 20년과 150,000회의 로봇 절제 수술에서 얻은 통찰력을 바탕으로 개발되었습니다.
MAGiC 카테터는 안정적인 접촉력으로 최적화된 내비게이션, iConnect 및 eContact 모듈 통합을 통한 개선된 데이터 수집, 환자 액체 부담을 줄이는 효율적인 저유량 냉각 등 향상된 기능을 특징으로 합니다. 이 장치는 심장 조직 내에서 국소 병변을 생성하여 심장 부정맥을 치료하기 위한 광범위한 유럽 승인을 받았습니다.
이번 승인은 개발, 테스트, 제조 및 임상 연구에 대한 광범위한 투자를 따른 결과입니다. 유럽의 임상 연구는 로봇 사용자의 폭넓은 채택에 대한 기대를 지지합니다.
Stereotaxis (NYSE: STXS) a reçu l'approbation du marquage CE européen pour son catheter d'ablation MAGiC™, conçu pour les interventions d'ablation cardiaque visant à traiter les arythmies cardiaques. Le cathéter a été développé sur la base de près de 20 ans d'expérience et de 150 000 procédures d'ablation robotiques utilisant des dispositifs antérieurs.
Le cathéter MAGiC présente des capacités améliorées, y compris une navigation optimisée avec des forces de contact constantes, une meilleure collecte de données grâce à l'intégration des modules iConnect et eContact, ainsi qu'une refroidissement efficace à faible débit qui réduit la charge de fluide des patients. L'appareil a reçu une large approbation européenne pour créer des lésions locales dans le tissu cardiaque pour traiter les arythmies cardiaques.
Cette approbation fait suite à d'importants investissements en développement, tests, fabrication et recherche clinique. Les études cliniques en Europe soutiennent les attentes d'une adoption généralisée parmi les utilisateurs robotiques.
Stereotaxis (NYSE: STXS) hat die europäische CE-Kennzeichnung für seinen MAGiC™ Ablationskatheter erhalten, der für kardiale Ablationsverfahren zur Behandlung von Herzrhythmusstörungen entwickelt wurde. Der Katheter wurde auf Basis von fast 20 Jahren und 150.000 robotergestützten Ablationsverfahren mit Vorgängergeräten entwickelt.
Der MAGiC-Katheter bietet verbesserte Funktionen, einschließlich optimierter Navigation mit konstanten Kontaktkräften, verbesserter Datenerfassung durch Integration der iConnect- und eContact-Module sowie effiziente Kühlung bei niedrigem Durchfluss, die die Flüssigkeitslast für den Patienten reduziert. Das Gerät erhielt eine umfassende europäische Genehmigung zur Erzeugung lokaler Läsionen im Herzgewebe zur Behandlung von Herzrhythmusstörungen.
Diese Genehmigung folgt umfangreichen Investitionen in Entwicklung, Test, Produktion und klinische Forschung. Klinische Studien in Europa unterstützen die Erwartungen an eine breite Akzeptanz unter den robotergestützten Nutzern.
- Received CE Mark approval for MAGiC ablation catheter in Europe
- Broad label approval for cardiac arrhythmia treatment
- Product builds on 150,000 procedures worth of experience
- Enhanced features including improved navigation and data collection
- None.
Insights
The CE Mark approval for Stereotaxis' MAGiC ablation catheter marks a pivotal milestone in the $4.7 billion global cardiac ablation market. This achievement is particularly significant as it represents the first major catheter innovation from Stereotaxis in over a decade, addressing a critical need in their product portfolio.
The technology's sophisticated features - including optimized magnetic navigation, enhanced force sensing and efficient cooling systems - position it competitively against manual ablation catheters from industry giants like Biosense Webster and Abbott. The broad European approval for cardiac arrhythmia treatment significantly expands the addressable market, potentially accelerating adoption among the existing installed base of Stereotaxis robotic systems in Europe.
Three key strategic implications stand out:
- The MAGiC catheter could drive higher utilization rates of existing Stereotaxis systems, potentially increasing high-margin recurring revenue from procedures
- Enhanced features may attract new hospital installations, expanding the installed base
- The successful CE Mark could accelerate the regulatory pathway in other markets, particularly supporting the ongoing FDA review process
The low-flow irrigation design is particularly noteworthy, as it reduces patient fluid load while maintaining effective cooling - a meaningful clinical differentiator that could support premium pricing. This approval positions Stereotaxis to potentially capture a larger share of the growing electrophysiology market, though success will depend on execution in training, marketing and establishing real-world clinical evidence.
ST. LOUIS, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it received European CE Mark approval for the MAGiC™ ablation catheter. This approval is a significant milestone for Stereotaxis and for the community of physicians pioneering robotics in electrophysiology. It is reflective of the company’s commitment to advancing significant innovations that make robotics increasingly impactful across interventional medicine.
Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The MAGiC catheter was developed based on insights collected over the course of nearly 20 years and 150,000 robotic ablation procedures performed using predecessor catheters. 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. It builds upon existing benefits of robotic cardiac ablation with design enhancements that include:
- Optimized Navigation, Force & Stability – The unique placement of magnets and design of the distal section of the catheter supports intuitive navigation, consistent contact forces, and enhanced stability.
- Improved Data & Information – MAGiC is available with iConnect and the eContact module, offering catheter tissue contact information as well as clear electrogram and responsive temperature data to support physician decision making.
- Efficient Low-Flow Uniform Cooling – Cooling of the tip is accomplished with low-flow irrigation that substantially reduces overall fluid load on patients while protecting against char and coagulation.
The MAGiC catheter has been approved in Europe with a broad label that includes the delivery of “local lesions in cardiac tissue for the treatment of cardiac arrhythmias.” Obtaining the CE Mark follows years of effort and substantial investments in catheter development, testing, manufacturing, and preclinical and clinical research. Clinical experience with MAGiC in an ongoing clinical study in Europe supports expectations for broad adoption of MAGiC across robotic users.
“We are thrilled to announce this significant milestone and introduce the MAGiC catheter to European physicians and patients,” said David Fischel, Stereotaxis Chairman and CEO. “We want to thank and recognize the significant contributions from clinicians who guided us throughout the development efforts and team members of Stereotaxis and Osypka that made this possible. We look forward to seeing MAGiC serve as one of the key pillars in our effort to make robotics broadly impactful and beneficial in electrophysiology and endovascular surgery.”
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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