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AtriCure, Inc, a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced the first use of the newest AtriClip ® device for minimally invasive concomitant procedures, the AtriClip PRO-Mini® LAA Exclusion System.
AtriCure, Inc. 是一家在心房颤动 (Afib) 手术治疗和疗法、左心耳 (LAA) 管理以及术后疼痛管理领域的领先创新者,今天宣布了其最新的 AtriClip® 设备在微创伴随手术中的首次应用,即 AtriClip PRO-Mini® LAA 闭合系统。
The AtriClip PRO-Mini device received FDA 510K clearance earlier this year and is a testament to AtriCure’s commitment to innovating the lowest profile and most effective surgical LAA devices on the market..
AtriClip PRO-Mini 设备在今年早些时候获得了 FDA 510K 的批准,这证明了 AtriCure 致力于创新市场上最低轮廓和最有效的外科 LAA 设备。
Building upon the proven technology of AtriCure’s AtriClip platform as the most widely implanted surgical LAA device globally, the AtriClip PRO-Mini device is preloaded with the smallest surgical LAA Management implant available in the market. This revolutionary implant is 60% smaller than the next lowest profile AtriClip device.
基于AtriCure的AtriClip平台经过验证的技术,这是全球最广泛植入的外科左心耳(LAA)设备,AtriClip PRO-Mini设备预装了市场上最小的外科LAA管理植入物。这款革命性的植入物比目前轮廓最低的AtriClip设备还要小60%。
This significant size reduction provides surgeons with enhanced visualization, ensuring precise and secure exclusion of the LAA during minimally invasive procedures..
这种显著的尺寸减小为外科医生提供了增强的可视化效果,确保在微创手术过程中精确且安全地排除LAA。
“The AtriClip PRO-Mini device represents a leap forward in surgical LAA management,' said Michael Carrel, President and Chief Executive Officer at AtriCure. 'This device demonstrates our unwavering commitment to innovating best-in-class surgical solutions and builds upon our 20+ year legacy in surgical appendage management.
“ AtriClip PRO-Mini 设备代表了手术 LAA 管理方面的一次飞跃,”AtriCure 总裁兼首席执行官 Michael Carrel 表示。“该设备展示了我们对创新一流的手术解决方案的坚定承诺,并且延续了我们在手术附件管理领域 20 多年的传承。
This technology is empowering surgeons with improved visualization and precision.”.
这项技术通过增强可视化和精确性,赋予外科医生更强的能力。
The AtriClip PRO-Mini device offers significant benefits to surgeons, including:
AtriClip PRO-Mini 设备为外科医生提供了显著的优势,包括:
Significant Size Reduction:
显著的尺寸减小:
The lower profile enhances visualization and enables precise placement, which is particularly important in minimally invasive procedures.
较低的轮廓增强了可视化,并能够实现精确放置,这在微创手术中尤为重要。
Consistent and Secure Exclusion:
一致且安全的排除:
Designed to apply uniform pressure, it ensures reliable and permanent LAA closure consistent with other AtriClip products.
设计用于施加均匀压力,确保与其他AtriClip产品一致的可靠且永久的LAA闭合。
Familiar and Trusted Applier Technology:
熟悉且值得信赖的应用技术:
Featuring omnidirectional head articulation, end effector lock, ambidextrous lever release trigger, and streamlined applier removal, similar to the AtriClip PRO2® LAA Exclusion System.
具有全向头部关节、末端执行器锁定、双手杠杆释放触发器和简化的施用器移除功能,类似于AtriClip PRO2® LAA排除系统。
'The AtriClip PRO-Mini device immediately impressed me with its significantly smaller profile,” said Dr. Ahmed Romeya, cardiovascular surgeon at Midwest Heart and Vascular Specialists in Overland Park, Kansas. “It maintained the parallel closure and uniform pressure necessary for effective left atrial appendage exclusion.
“这款AtriClip PRO-Mini设备显著小巧的外形立即给我留下了深刻印象,”堪萨斯州欧弗兰帕克中西部心脏和血管专科医生、心血管外科医生艾哈迈德·罗梅亚博士说道,“它保持了平行闭合和有效左心耳排除所需的均匀压力。”
The enhanced visualization offered by the AtriClip PRO-Mini device will undoubtedly increase surgeon confidence during these procedures.'.
AtriClip PRO-Mini 设备提供的增强可视化无疑会增加外科医生在这些手术中的信心。
For more information about the AtriClip line of products, visit our website at www.atricure.com/laa-exclusion
有关 AtriClip 系列产品的更多信息,请访问我们的网站 www.atricure.com/laa-exclusion。
Forward-Looking Statements
前瞻性声明
Certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements.
本新闻稿中的某些陈述具有前瞻性,涉及与我们相关的风险、不确定性和假设。我们的业务和运营受到各种风险和不确定性的影响,因此,实际结果可能与任何前瞻性陈述中预计的结果存在重大差异。
These risks and uncertainties include, but are not limited to, the following: our estimate of the market for our products; the rate and degree of market acceptance of our products; negative clinical data; competition from existing and new products and procedures, including the development of drugs or catheter-based technologies; our reliance on independent distributors to sell our products; inventory-related charges; the timing of and ability to obtain and maintain regulatory clearances and approvals for our products; impacts of rising healthcare costs; our ability to comply with extensive FDA regulations; the timing of and ability to obtain third party payor reimbursement of procedures utilizing our products; unfavorable publicity; the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make; disruptions to our manufacturing operations; our failure to properly manage growth; disruptions of critical information systems or material breaches in the security of our systems; our ability to manage our intellectual property rights to provide meaningful protection; fluctuation of quarterly financial results; fluctuations in foreign currency exchange rates; reliance on third party manufacturers and suppliers; and litigation, administrative or other proceedings.
这些风险和不确定性包括但不限于以下内容:我们对产品市场的估计;我们的产品在市场中的接受率和接受程度;负面的临床数据;来自现有和新产品及程序的竞争,包括药物或基于导管技术的开发;我们依赖独立分销商销售我们的产品;与库存相关的费用;获得和维持我们产品的监管许可和批准的时间和能力;医疗成本上升的影响;我们遵守广泛的FDA法规的能力;获得第三方支付方对我们产品所涉及程序报销的时间和能力;不利的宣传;我们可能进行的任何收购、合并、处置、合资或投资的潜在影响;对我们制造业务的干扰;我们未能妥善管理增长;关键信息系统中断或系统安全的重大漏洞;我们管理知识产权以提供有效保护的能力;季度财务结果的波动;外汇汇率的波动;依赖第三方制造商和供应商;以及诉讼、行政或其他程序。
These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission ('SEC'), i.
这些风险和不确定性,以及其他风险,都在我们向证券交易委员会(“SEC”)提交的文件中有更详细的讨论,即。
About AtriCure
关于AtriCure
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 59 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications, and the treatment of post-operative pain.
AtriCure公司提供用于治疗房颤及相关病症的创新技术。房颤影响着全球超过5900万人。世界各地的心脏电生理学家、心胸外科医生和胸外科医生使用AtriCure的技术来治疗房颤、减少房颤相关并发症以及术后疼痛的治疗。
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的Isolator® Synergy™消融系统是首个获得FDA批准用于治疗持续性房颤的医疗设备。AtriCure的AtriClip®左心耳封堵系统产品是全球最畅销的左心耳管理设备。AtriCure的Hybrid AF™疗法是一种微创手术,为长期持续性房颤患者提供了持久的解决方案。
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 Twitter @AtriCure..
AtriCure的cryoICE cryoSPHERE® 探头已被批准用于暂时性消融外周神经以阻断疼痛,在心脏和胸部手术中提供镇痛效果。欲了解更多信息,请访问AtriCure.com或在Twitter上关注我们@AtriCure。
Contacts
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Angie Wirick
安吉·威里克
Investor Relations
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Chief Financial Officer
首席财务官
(513) 755-5334
(513) 755-5334
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Valerie Storch-Willhaus
瓦莱丽·斯托奇-威尔豪斯
Media Relations
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Vice President, Corporate Marketing & Communications
副总裁,企业营销与传播
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Source: businesswire.com
来源:businesswire.com