Magbot Robotic Magnetic Navigation Ablation Catheter Approved by China’s NMPA
Stereotaxis (NYSE: STXS) and MicroPort EP announced that China's NMPA has approved the Magbot™ Magnetic Navigation Ablation Catheter. This single-use magnetic saline-irrigated radiofrequency ablation catheter works exclusively with Stereotaxis' robotic systems and MicroPort EP's Columbus™ 3D EP Mapping System.
The Magbot™ features advanced design elements including a unique six-electrode configuration for enhanced safety and reduced fluoroscopy needs. It's approved for treating drug-resistant persistent atrial fibrillation and other cardiac conditions. The catheter enables precise positioning with millimeter-level accuracy using low-intensity magnetic fields.
MicroPort EP will handle the commercial launch in China through its existing sales team, with Stereotaxis sharing in the proceeds from Magbot™ adoption.
Stereotaxis (NYSE: STXS) e MicroPort EP hanno annunciato che la NMPA della Cina ha approvato il Catetere di Ablazione Magnetica Magbot™. Questo catetere per ablazione a radiofrequenza, irrigato con soluzione salina, è monouso e funziona esclusivamente con i sistemi robotici di Stereotaxis e con il Sistema di Mappatura EP Columbus™ di MicroPort EP.
Il Magbot™ presenta elementi di design avanzati, tra cui una configurazione unica a sei elettrodi per una maggiore sicurezza e una riduzione della necessità di fluoroscopia. È approvato per il trattamento della fibrillazione atriale persistente resistente ai farmaci e di altre condizioni cardiache. Il catetere consente un posizionamento preciso con un’accuratezza a livello millimetrico utilizzando campi magnetici a bassa intensità.
MicroPort EP gestirà il lancio commerciale in Cina attraverso il suo attuale team di vendita, mentre Stereotaxis condividerà i proventi dall'adozione del Magbot™.
Stereotaxis (NYSE: STXS) y MicroPort EP han anunciado que la NMPA de China ha aprobado el Catéter de Ablación de Navegación Magnética Magbot™. Este catéter de ablación por radiofrecuencia, irrigado con solución salina, es de un solo uso y funciona exclusivamente con los sistemas robóticos de Stereotaxis y con el Sistema de Mapeo EP Columbus™ de MicroPort EP.
El Magbot™ cuenta con elementos de diseño avanzados, incluyendo una configuración única de seis electrodos para una mayor seguridad y una reducción de las necesidades de fluoroscopia. Está aprobado para el tratamiento de la fibrilación auricular persistente resistente a medicamentos y otras condiciones cardíacas. El catéter permite un posicionamiento preciso con una exactitud a nivel milimétrico utilizando campos magnéticos de baja intensidad.
MicroPort EP manejará el lanzamiento comercial en China a través de su equipo de ventas existente, mientras que Stereotaxis compartirá los ingresos de la adopción del Magbot™.
스테레오택시스(Stereotaxis, NYSE: STXS)와 마이크로포트 EP(MicroPort EP)가 중국 NMPA가 마그봇™ 자성 내비게이션 절제 카테터를 승인했다고 발표했습니다. 이 일회용 자성 생리 식염수로 관류하는 고주파 절제 카테터는 스테레오택시스의 로봇 시스템과 마이크로포트 EP의 콜럼버스™ 3D EP 맵핑 시스템과 독점적으로 작동합니다.
마그봇™은 최대한의 안전성과 방사선 촬영 필요성을 줄이기 위해 독특한 6전극 구성 등 진보된 설계 요소가 특징입니다. 약물 내성의 지속적인 심방 세동 및 기타 심장 질환 치료를 위해 승인되었습니다. 이 카테터는 저강도 자기장을 사용하여 밀리미터 수준의 정확도로 정밀한 위치 결정을 가능하게 합니다.
마이크로포트 EP는 기존 판매 팀을 통해 중국에서 상업적 출시를 관리하며, 스테레오택시스는 마그봇™ 채택에서 발생하는 수익을 공유할 것입니다.
Stereotaxis (NYSE: STXS) et MicroPort EP ont annoncé que la NMPA de Chine a approuvé le Cathéter d'Ablation par Navigation Magnétique Magbot™. Ce cathéter à radiofréquence, à usage unique, irrigué par une solution saline, fonctionne exclusivement avec les systèmes robotiques de Stereotaxis et le Système de Cartographie EP Columbus™ de MicroPort EP.
Le Magbot™ dispose d'éléments de conception avancés, y compris une configuration unique à six électrodes pour une sécurité accrue et une réduction des besoins en fluoroscopie. Il est approuvé pour le traitement de la fibrillation auriculaire persistante résistante aux médicaments et d'autres conditions cardiaques. Le cathéter permet un positionnement précis avec une précision au millimètre près en utilisant des champs magnétiques de faible intensité.
MicroPort EP gérera le lancement commercial en Chine via son équipe de vente existante, tandis que Stereotaxis partagera les revenus de l'adoption du Magbot™.
Stereotaxis (NYSE: STXS) und MicroPort EP haben bekannt gegeben, dass die NMPA in China den Magbot™ Magnetnavigation-Ablationskatheter genehmigt hat. Dieser einmal verwendbare, mit isotonischer Kochsalzlösung durchspülte Radiofrequenz-Ablationskatheter funktioniert ausschließlich mit den robotergestützten Systemen von Stereotaxis und dem Columbus™ 3D EP-Mapping-System von MicroPort EP.
Der Magbot™ verfügt über fortschrittliche Designelemente, darunter eine einzigartige Sechs-Elektroden-Konfiguration für erhöhte Sicherheit und reduzierte Fluoroskopie-Bedürfnisse. Er ist zur Behandlung von medikamentenresistenter persistierender Vorhofflimmern und anderen Herzkrankheiten zugelassen. Der Katheter ermöglicht eine präzise Positionierung mit millimetergenauer Genauigkeit unter Verwendung von niederintensiven Magnetfeldern.
MicroPort EP wird den kommerziellen Markteintritt in China über sein bestehendes Vertriebsteam abwickeln, während Stereotaxis an den Erlösen aus der Einführung des Magbot™ beteiligt sein wird.
- NMPA approval for Magbot™ Catheter opens access to Chinese market
- Revenue sharing agreement with MicroPort EP for Magbot™ sales
- Integration with existing Stereotaxis robotic systems and MicroPort EP's mapping system
- Enhanced safety features reducing fluoroscopy requirements
- None.
Insights
ST. LOUIS and SHANGHAI, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS) and Shanghai MicroPort EP Medtech Co., Ltd. (688351.SH, “MicroPort EP”), today announced that the Magbot™ Magnetic Navigation Ablation Catheter has received regulatory approval from China’s National Medical Products Administration (NMPA).
The Magbot™ Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by MicroPort EP in collaboration with Stereotaxis. The catheter works exclusively and in tight conjunction with Stereotaxis’ robotic systems, including the recently NMPA-approved Genesis RMN™, and MicroPort EP’s Columbus™ 3D EP Mapping System.
Magbot™ incorporates advanced design features that substantially enhance the efficiency, effectiveness, and safety of robotic magnetic catheter ablation. Robotically navigated using low-intensity magnetic fields, the Magbot™ catheter is able to reach areas of the heart otherwise difficult to access with traditional methods and to maintain precise positioning and stability on cardiac anatomy with millimeter-level accuracy. Full integration with Columbus™ enables real-time location tracking and 3D cardiac modeling, allowing physicians to accurately record electrocardiographic data and pinpoint lesions for precise diagnosis and treatment of arrhythmias. A unique six-electrode design enhances safety during procedures by offering visibility of the catheter shaft without the need for fluoroscopy. Magbot™ has been approved by NMPA for the ablation of drug-resistant persistent atrial fibrillation, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.
“The approval of the Magbot™ Catheter signifies a major breakthrough for MicroPort EP in cardiac electrophysiology and a significant milestone for robotic navigation technology in China,” emphasized Dr. Yiyong Sun, President of MicroPort EP. “Our recent technological advances with Stereotaxis offer a safer and more precise minimally-invasive treatment solution for complex arrhythmia patients. We are excited about its potential to benefit physicians and patients alike and to strengthen our partnership with Stereotaxis to drive innovation in electrophysiology.”
“We are delighted by Magbot™ approval in China,” added David Fischel, Chairman and CEO of Stereotaxis. “This milestone reflects our commitment to improving global cardiovascular care. Magbot™ represents a key innovation in robotic navigation, and we look forward to continuing our collaboration with MicroPort EP to pioneer innovative technologies that advance electrophysiology and benefit patients worldwide.”
MicroPort EP will initiate commercial launch of Magbot™ in China through its existing sales team focused on the electrophysiology community. Stereotaxis shares in the proceeds from Magbot™ adoption. MicroPort EP is one of China’s leading medical device companies with a portfolio of cardiovascular medical devices designed to diagnose and treat arrythmias. Stereotaxis and MicroPort EP previously announced their collaboration in August 2021.
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, and 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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