Stereotaxis Submits First Ever Robotically Navigated High-Density EP Mapping Catheter for Regulatory Clearance
Stereotaxis (NYSE: STXS) has submitted its MAGiC Sweep™ catheter for FDA regulatory clearance, marking a significant milestone as the first high-density EP mapping catheter designed for robotic navigation using Stereotaxis' Robotic Magnetic Navigation systems.
The innovative catheter offers several advantages: rapid electroanatomical mapping from 20 electrodes simultaneously, enhanced safety through atraumatic design, improved access to difficult heart areas, better robotic workflow, and more accurate anatomical mapping. The company plans to submit for European CE Mark clearance this month.
MAGiC Sweep, designed and manufactured by Stereotaxis' subsidiary Access Point Technologies in Minnesota, is expected to launch commercially in the second half of 2025 following anticipated approvals. This development represents the first dedicated diagnostic catheter for Stereotaxis' robotic technology, complementing their existing robotic ablation catheter innovations.
Stereotaxis (NYSE: STXS) ha presentato il suo catetere MAGiC Sweep™ per l'approvazione normativa da parte della FDA, segnando un traguardo significativo come il primo catetere di mappatura EP ad alta densità progettato per la navigazione robotica utilizzando i sistemi di Navigazione Magnetica Robotica di Stereotaxis.
Il catetere innovativo offre diversi vantaggi: mappatura elettroanatomica rapida da 20 elettrodi simultaneamente, maggiore sicurezza grazie a un design atraumatico, accesso migliorato a zone cardiache difficili, un flusso di lavoro robotico ottimizzato e una mappatura anatomica più precisa. L'azienda prevede di presentare la richiesta per l'approvazione del marchio CE europeo questo mese.
Il MAGiC Sweep, progettato e prodotto dalla controllata di Stereotaxis, Access Point Technologies, in Minnesota, dovrebbe essere lanciato commercialmente nella seconda metà del 2025, a seguito delle approvazioni previste. Questo sviluppo rappresenta il primo catetere diagnostico dedicato per la tecnologia robotica di Stereotaxis, completando le loro attuali innovazioni nel catetere per ablazione robotica.
Stereotaxis (NYSE: STXS) ha presentado su catéter MAGiC Sweep™ para la aprobación regulatoria de la FDA, marcando un hito significativo como el primer catéter de mapeo EP de alta densidad diseñado para la navegación robótica utilizando los sistemas de Navegación Magnética Robótica de Stereotaxis.
El catéter innovador ofrece varias ventajas: mapeo electroanatómico rápido desde 20 electrodos simultáneamente, mayor seguridad gracias a su diseño atraumático, mejor acceso a áreas cardíacas difíciles, un flujo de trabajo robótico mejorado y un mapeo anatómico más preciso. La empresa planea solicitar la aprobación del marcado CE europeo este mes.
El MAGiC Sweep, diseñado y fabricado por la subsidiaria de Stereotaxis, Access Point Technologies, en Minnesota, se espera que se lance comercialmente en la segunda mitad de 2025 tras las aprobaciones anticipadas. Este desarrollo representa el primer catéter diagnóstico dedicado para la tecnología robótica de Stereotaxis, complementando sus innovaciones existentes en catéteres de ablación robótica.
스테레오택시스 (NYSE: STXS)는 FDA 규제 승인을 위한 MAGiC Sweep™ 카테터를 제출하였으며, 이는 스테레오택시스의 로봇 자기 내비게이션 시스템을 사용하여 로봇 내비게이션을 위해 설계된 최초의 고밀도 EP 매핑 카테터로서 중요한 이정표를 나타냅니다.
이 혁신적인 카테터는 여러 가지 장점을 제공합니다: 20개의 전극으로 동시에 빠른 전기 해부학적 매핑, 비외상적 디자인으로 인한 안전성 향상, 어려운 심장 부위에 대한 접근성 개선, 향상된 로봇 작업 흐름 및 더 정확한 해부학적 매핑. 회사는 이번 달에 유럽 CE 마크 승인을 신청할 계획입니다.
MAGiC Sweep는 스테레오택시스의 자회사인 Access Point Technologies가 미네소타에서 설계 및 제조하였으며, 예상되는 승인을 받은 후 2025년 하반기에 상업적으로 출시될 예정입니다. 이 개발은 스테레오택시스의 로봇 기술을 위한 최초의 전용 진단 카테터를 나타내며, 기존의 로봇 절제 카테터 혁신을 보완합니다.
Stereotaxis (NYSE: STXS) a soumis son cathéter MAGiC Sweep™ pour l'approbation réglementaire de la FDA, marquant une étape importante en tant que premier cathéter de cartographie EP haute densité conçu pour la navigation robotique utilisant les systèmes de Navigation Magnétique Robotique de Stereotaxis.
Ce cathéter innovant offre plusieurs avantages : cartographie électro-anatomique rapide à partir de 20 électrodes simultanément, sécurité accrue grâce à un design atraumatique, meilleur accès aux zones cardiaques difficiles, flux de travail robotique amélioré et cartographie anatomique plus précise. L'entreprise prévoit de demander l'approbation du marquage CE européen ce mois-ci.
Le MAGiC Sweep, conçu et fabriqué par la filiale de Stereotaxis, Access Point Technologies, dans le Minnesota, devrait être lancé commercialement au cours de la seconde moitié de 2025, après les approbations anticipées. Ce développement représente le premier cathéter de diagnostic dédié pour la technologie robotique de Stereotaxis, complétant leurs innovations existantes en matière de cathéters d'ablation robotique.
Stereotaxis (NYSE: STXS) hat seinen MAGiC Sweep™ Katheter zur Genehmigung durch die FDA eingereicht, was einen bedeutenden Meilenstein darstellt, da es sich um den ersten hochdichten EP-Mapping-Katheter handelt, der für die robotergestützte Navigation mit den Robotischen Magnetnavigation-Systemen von Stereotaxis entwickelt wurde.
Der innovative Katheter bietet mehrere Vorteile: schnelles elektroanatomisches Mapping von 20 Elektroden gleichzeitig, erhöhte Sicherheit durch atraumatisches Design, verbesserter Zugang zu schwierigen Herzbereichen, optimierter robotergestützter Arbeitsablauf und genauere anatomische Abbildung. Das Unternehmen plant, in diesem Monat die Genehmigung für das europäische CE-Zeichen zu beantragen.
Der MAGiC Sweep, entworfen und hergestellt von der Tochtergesellschaft von Stereotaxis, Access Point Technologies in Minnesota, wird voraussichtlich in der zweiten Hälfte des Jahres 2025 kommerziell eingeführt, nachdem die erwarteten Genehmigungen vorliegen. Diese Entwicklung stellt den ersten speziellen Diagnostik-Katheter für die robotergestützte Technologie von Stereotaxis dar und ergänzt deren bestehende Innovationen im Bereich robotergestützter Ablationskatheter.
- First-to-market robotically navigated high-density EP mapping catheter
- Product manufactured in-house through owned subsidiary
- Expansion of product portfolio beyond ablation catheters
- Dual market opportunity with planned FDA and CE Mark submissions
- Revenue impact dependent on regulatory approvals
- Commercial launch not expected until H2 2025
- Success contingent on market adoption and competition
Insights
Stereotaxis' FDA submission for MAGiC Sweep™ represents a potential inflection point in the company's strategic evolution. As the first-ever robotically navigated high-density mapping catheter, this technology directly addresses a critical adoption barrier for Stereotaxis' robotic navigation systems. Electrophysiologists have historically been forced to choose between robotic precision and the comprehensive data provided by high-density mapping - this innovation eliminates that trade-off.
This submission is particularly significant as it represents Stereotaxis' expansion from primarily selling capital equipment to developing a recurring revenue stream through proprietary catheters. The technology offers clear clinical advantages: simultaneous data collection from 20 electrodes, reduced tissue damage through atraumatic design, access to anatomically challenging cardiac regions, and potentially more accurate mapping by avoiding tissue distension.
What's equally noteworthy is that MAGiC Sweep was developed by Stereotaxis' wholly-owned subsidiary Access Point Technologies, demonstrating vertical integration that should improve margins while accelerating future catheter development. With European CE Mark submission planned this month and commercial launch anticipated in H2 2025, this product - along with the separately announced EMAGIN 5F vascular catheter - marks the company's strategic transformation into a comprehensive robotics platform with multiple proprietary catheter offerings.
For Stereotaxis to fully capitalize on this opportunity, they'll need to navigate regulatory timelines, scale manufacturing capabilities, and effectively compete against established high-density mapping systems from larger competitors. This submission is just the first step in a critical strategic pivot that could significantly expand Stereotaxis' addressable market.
ST. LOUIS, March 03, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced FDA regulatory submission for the MAGiC Sweep™ catheter. MAGiC Sweep is the first high-density EP mapping catheter developed to be robotically navigated using Stereotaxis’ Robotic Magnetic Navigation systems.
High density mapping has transformed the EP field, enhancing cardiac ablation procedures by enabling more efficient, detailed and precise identification of arrhythmia origin. The combination of high-density mapping with robotics is designed to offer multiple improvements over what has been available: highly rapid and detailed electroanatomical mapping collected simultaneously from 20 electrodes, mapping with the inherent safety of an atraumatic catheter, the ability to map otherwise difficult to reach areas of the heart, improved robotic procedural workflow, and more anatomically accurate maps by avoiding the distension caused by rigid catheters. Stereotaxis’ robotic technology allows for automated mapping that will be enhanced in combination with MAGiC Sweep.
“The development of the first ever robotically navigated high-density mapping catheter is a major milestone for the EP field,” said Dr. Roderick Tung, Chief of Cardiology and Director of Cardiovascular Clinical Research at The University of Arizona College of Medicine - Phoenix. “Mapping with multi-electrode catheters has taught us so much in both mechanism and therapy for both atrial and ventricular arrhythmias. Remaining limited to only point-by-point mapping has held back the adoption of robotic navigation, as we have become accustomed to seeing human arrhythmias in exquisitely high resolution. We look forward to the positive impact we expect MAGiC Sweep to have on our patients and new possibilities in the field.”
Stereotaxis submitted a 510(k) application for MAGiC Sweep with the FDA and expects to submit MAGiC Sweep for European CE Mark clearance this month. MAGiC Sweep was designed and is manufactured by Stereotaxis’ fully-owned subsidiary Access Point Technologies in Minnesota. Stereotaxis expects to initiate a broad commercial launch of MAGiC Sweep following anticipated approvals in the second half of this year. This is the first dedicated diagnostic catheter made available for Stereotaxis’ robotic technology, complementing robotic ablation catheter innovations.
“Stereotaxis is rapidly evolving towards becoming a robotic leader with a broad portfolio of proprietary differentiated catheters,” said David Fischel, Stereotaxis Chairman and CEO. “The acquisition of Access Point Technologies reflected our commitment to this strategy and has accelerated our progress. The submissions of MAGiC Sweep – along with our first vascular guidance catheter EMAGIN 5F, announced in a separate press release this morning – reflect the first tangible milestones in this strategic transformation.”
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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