AtriCure Receives Regulatory Approval to Sell AtriClip® Devices in China
AtriCure, Inc. (Nasdaq: ATRC) has received regulatory approval from China's National Medical Products Administration (NMPA) to market and sell several models of its AtriClip® Left Atrial Appendage (LAA) Exclusion System. This innovative device is designed to exclude and electrically isolate the LAA during cardiac surgery, addressing a major source of blood clots in patients with atrial fibrillation (Afib).
The approval marks a significant milestone in AtriCure's global expansion strategy, opening up a substantial market opportunity in China. The company plans to partner with leading medical institutions and professionals in China to provide comprehensive training and support. AtriClip devices have been successfully used in over 550,000 patients worldwide, demonstrating robust clinical data on safety and efficacy.
AtriCure, Inc. (Nasdaq: ATRC) ha ricevuto l'approvazione normativa dalla National Medical Products Administration (NMPA) della Cina per commercializzare e vendere diversi modelli del suo AtriClip® Left Atrial Appendage (LAA) Exclusion System. Questo dispositivo innovativo è progettato per escludere e isolare elettricamente l'appendice atriale sinistra durante la chirurgia cardiaca, affrontando una delle principali fonti di coaguli di sangue nei pazienti con fibrillazione atriale (Afib).
L'approvazione segna una tappa significativa nella strategia di espansione globale di AtriCure, aprendo un'opportunità di mercato sostanziale in Cina. L'azienda prevede di collaborare con importanti istituzioni e professionisti medici in Cina per fornire formazione e supporto completi. I dispositivi AtriClip sono stati utilizzati con successo in oltre 550.000 pazienti in tutto il mondo, dimostrando dati clinici solidi sulla sicurezza e l'efficacia.
AtriCure, Inc. (Nasdaq: ATRC) ha recibido la aprobación regulatoria de la Administración Nacional de Productos Médicos de China (NMPA) para comercializar y vender varios modelos de su AtriClip® Left Atrial Appendage (LAA) Exclusion System. Este dispositivo innovador está diseñado para excluir y aislar eléctricamente la apéndice auricular izquierda durante la cirugía cardíaca, abordando una de las principales fuentes de coágulos sanguíneos en pacientes con fibrilación auricular (Afib).
La aprobación marca un hito significativo en la estrategia de expansión global de AtriCure, abriendo una oportunidad de mercado sustancial en China. La empresa planea asociarse con instituciones y profesionales médicos líderes en China para proporcionar formación y apoyo integral. Los dispositivos AtriClip han sido utilizados con éxito en más de 550,000 pacientes en todo el mundo, demostrando datos clínicos sólidos sobre la seguridad y eficacia.
AtriCure, Inc. (Nasdaq: ATRC)는 중국 국가의약품감독관리국(NMPA)으로부터 AtriClip® Left Atrial Appendage (LAA) Exclusion System의 여러 모델을 판매할 수 있는 규제 승인을 받았습니다. 이 혁신적인 장치는 심장 수술 중 LAA를 배제하고 전기적으로 격리하기 위해 설계되었으며, 심방 세동(Afib) 환자에서 혈전의 주요 원인을 해결합니다.
이번 승인은 AtriCure의 글로벌 확장 전략에서 중요한 이정표로, 중국에서 상당한 시장 기회를 열어줍니다. 회사는 중국 내 주요 의료 기관 및 전문가와 협력하여 포괄적인 교육 및 지원을 제공할 계획입니다. AtriClip 장치는 전 세계에서 550,000명 이상의 환자에게 성공적으로 사용되었으며, 안전성과 유효성에 대한 강력한 임상 데이터를 보여주고 있습니다.
AtriCure, Inc. (Nasdaq: ATRC) a reçu l'approbation réglementaire de l'Administration nationale des produits médicaux de Chine (NMPA) pour commercialiser et vendre plusieurs modèles de son AtriClip® Left Atrial Appendage (LAA) Exclusion System. Ce dispositif innovant est conçu pour exclure et isoler électriquement l'apendice auriculaire gauche pendant la chirurgie cardiaque, traitant ainsi une importante source de caillots sanguins chez les patients atteints de fibrillation auriculaire (Afib).
Cette approbation marque une étape significative dans la stratégie d'expansion mondiale d'AtriCure, ouvrant ainsi une opportunité de marché substantielle en Chine. L'entreprise prévoit de s'associer à des institutions et des professionnels médicaux de premier plan en Chine pour fournir une formation et un soutien complets. Les dispositifs AtriClip ont été utilisés avec succès chez plus de 550 000 patients dans le monde entier, démontrant des données cliniques solides sur la sécurité et l'efficacité.
AtriCure, Inc. (Nasdaq: ATRC) hat von der National Medical Products Administration (NMPA) Chinas eine regulatorische Genehmigung erhalten, um mehrere Modelle seines AtriClip® Left Atrial Appendage (LAA) Exclusion System zu vermarkten und zu verkaufen. Dieses innovative Gerät soll das LAA während der Herzchirurgie ausschließen und elektrisch isolieren und somit eine wichtige Quelle für Blutgerinnsel bei Patienten mit Vorhofflimmern (Afib) angehen.
Die Genehmigung markiert einen bedeutenden Meilenstein in der globalen Expansionsstrategie von AtriCure und eröffnet eine erhebliche Marktchance in China. Das Unternehmen plant, mit führenden medizinischen Institutionen und Fachleuten in China zusammenzuarbeiten, um umfassende Schulungen und Unterstützung anzubieten. AtriClip-Geräte wurden weltweit erfolgreich bei über 550.000 Patienten eingesetzt und zeigen solide klinische Daten zur Sicherheit und Wirksamkeit.
- Received regulatory approval to sell AtriClip devices in China
- Expands market opportunity in a significant new region
- AtriClip devices have been used in over 550,000 patients worldwide
- Plans to partner with leading medical institutions in China for training and support
- None.
Insights
The approval of AtriCure's AtriClip devices in China is a significant milestone in the medical device industry, particularly for the cardiac care sector. With atrial fibrillation being a major health issue globally, the ability to market an innovative device that isolates the left atrial appendage will potentially improve patient outcomes significantly. The regulatory approval by the National Medical Products Administration (NMPA) of China is a strong endorsement of the device's safety and efficacy.
Given the robust clinical data supporting the AtriClip's performance, this approval paves the way for extensive use in surgical procedures, aiming for better management of Afib-related complications. This strategic market entry into China, which has a large patient population, can dramatically boost the adoption rates of AtriCure's products.
From a market perspective, entering the Chinese market is a substantial opportunity for AtriCure. China's healthcare market is growing rapidly, with increasing demand for advanced medical technologies. Regulatory approval in China not only opens a new revenue stream but also strengthens AtriCure’s competitive positioning globally. With over 550,000 successful implementations of the AtriClip device worldwide, the expected uptake in China could significantly enhance the company's market share in the atrial fibrillation treatment segment.
Besides expanding market reach, this move aligns with AtriCure’s global expansion strategy, potentially leading to partnerships with top medical institutions and professionals in China. This strategy will likely result in a robust pipeline of future innovations and approvals, reinforcing the company's growth trajectory.
Financially, AtriCure's entry into the Chinese market represents a potential catalyst for revenue growth and shareholder value. The approval could lead to significant sales increases given the large patient population and growing healthcare expenditures in China. Furthermore, this development may positively impact AtriCure's stock price as investors anticipate substantial returns from the Chinese market’s lucrative healthcare sector.
This expansion is likely to improve AtriCure's financial health, providing additional revenue streams and enhancing profitability. Investors should monitor how swiftly the company can capitalize on this approval and establish its footprint in China, as this will be important for sustaining long-term financial growth and stability.
The AtriClip device is an innovative solution designed to exclude and electrically isolate the left atrial appendage during cardiac surgery. The LAA is a major source of blood clots in patients with Afib, and this approval marks a significant milestone in AtriCure’s mission to provide life-saving treatments for patients suffering from Afib and associated risks.
“We are committed to expanding access to treatment and enhancing patient outcomes globally and are thrilled to receive approval to treat patients with our AtriClip devices in China,” said Michael Carrel, President and CEO of AtriCure. “While patients have been benefitting from our surgical ablation devices in
The approval of the AtriClip device in
For more information about the AtriClip line of products, visit www.atricure.com/laa-exclusion.
Forward-Looking Statements
This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. Actual results could differ materially. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We assume no obligation to update any forward-looking statements contained in this release and the related attachment as a result of new information or future events or developments, except as may be required by law.
About AtriCure
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on X (formerly Twitter) @AtriCure.
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Angie Wirick
Investor Relations
Chief Financial Officer
(513) 755-5334
awirick@atricure.com
Valerie Storch-Willhaus
Media Relations
Vice President, Corporate Marketing & Communications
(612) 605-3311
vstorch-willhaus@atricure.com
Source: AtriCure, Inc.
FAQ
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