24, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced United States Food and Drug Administration (FDA) approval of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter..

242024/PRNewswire/--医疗保健技术的全球领导者美敦力公司（纽约证券交易所：MDT）今天宣布，美国食品和药物管理局（FDA）批准了带有Sphere-9™导管的Affera™标测和消融系统，这是一种一体式高密度（HD）标测和脉冲场（PF）以及射频（RF）消融导管，用于治疗持续性心房颤动（AFib）和射频消融腔三尖瓣峡部（CTI）依赖性心房扑动。。

With this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. The PulseSelect™ Pulsed Field Ablation System, which was FDA approved in December 2023, offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) while the Affera Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath..

有了这一批准，美敦力现在是第一家也是唯一一家为Afib患者提供两种PFA技术的公司。PulseSelect™脉冲场消融系统于2023年12月获得FDA批准，为医生提供了一种安全的单次肺静脉隔离（PVI）解决方案，而Affera Sphere-9导管凭借其广域聚焦设计和9mm可与8.5Fr护套一起使用的点阵尖端，为医生提供了治疗灵活性。。

'The significance of this innovative technology should be underscored; Affera is a game changer for treatment of Afib and atrial flutter,' said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. 'The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients.

“应该强调这种创新技术的重要性；纽约市西奈山卫生系统心律失常服务主任维韦克·雷迪（VivekReddy）医学博士说，阿费拉（Affera）是治疗Afib和心房扑动的游戏规则改变者Affera系统为医生提供了一种安全，有效和高效的解决方案，可以解决心脏病中常见且日益严重的问题，需要为患者提供优化的解决方案。

With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of Afib.'.

对于经验丰富的医生来说，学习曲线很短，治疗Afib的可能性是无限的。”。

With a trailblazing design, the Sphere-9 catheter offers physicians the option of both PF and RF energy delivery, fully integrated with the Affera Mapping and Ablation System. The Sphere-9 catheter enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.

Sphere-9导管具有开创性的设计，为医生提供了PF和RF能量输送的选择，与Affera标测和消融系统完全集成。Sphere-9导管提高了医生的工作效率，同时提供了出色的安全性和有效性结果。

'The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy,' said Doron Harlev, vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera.

“Affera系统旨在解决电生理学界面临的程序挑战，同时为患者保持高标准的安全性和有效性。美敦力（Medtronic）心脏消融解决方案工程（engineering for Cardiac ablation Solutions）副总裁、阿费拉（Affera）创始人多伦·哈列夫（DoronHarlev）说，Sphere-9导管通过实现单次经中隔、零透视和零交换工作流程，独特地集成了标测和消融技术，提供了使用脉冲场或射频能量的灵活性。

'This marks an exciting milestone for the field, with Medtronic's robust innovation pipeline poised to drive continued progress.'.

“这标志着该领域的一个激动人心的里程碑，美敦力强大的创新渠道将推动持续进步。”。

The approval was based on excellent results demonstrated in the pivotal SPHERE Per-AF study, an FDA Investigational Device Exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch® SF radiofrequency ablation catheter with the Carto™*3 System.

该批准基于FDA研究设备豁免（IDE）试验pivotal SPHERE Per AF study中显示的优异结果，该试验将SPHERE-9导管与Affera标测和消融系统与传统的Thermocool SmartTouch®SF射频消融导管与Carto™3系统进行了比较。

The Affera Mapping and Ablation System and Sphere-9 catheter also received CE Mark in March 2023 and was approved in Australia in September 2024. In October 2024, Medtronic announced the start of an early feasibility study to evaluate the Sphere-9 catheter for treatment of ventricular tachycardia (VT), a cardiac arrhythmia in which the lower chamber of the heart beats abnormally fast..

Affera标测和消融系统和Sphere-9导管也于2023年3月获得CE标志，并于2024年9月在澳大利亚获得批准。2024年10月，美敦力宣布开始进行早期可行性研究，以评估Sphere-9导管治疗室性心动过速（VT），室性心动过速是一种心律失常，其中下室跳动异常快。。

'At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients. With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient,' said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Medtronic Cardiovascular Portfolio.

“在美敦力，我们有75年的传统，将颠覆性创新带入市场，以我们的使命和承诺为指导，解决患者未满足的需求。心脏消融解决方案业务总裁丽贝卡·塞德尔（RebeccaSeidel）说，在阿费拉（Affera）的批准下，我们很高兴能为临床医生带来一种新颖的标测和消融解决方案，旨在使心房颤动治疗更安全，更有效，更高效。

'The potential of Affera is limitless. We will continue to fulfill our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes.'.

“阿费拉的潜力是无限的。我们将继续履行创新承诺，包括新的适应症，以推进心血管护理并改善患者预后。”。

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.1 Afib is a progressive disease, often beginning as paroxsymal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases2-5..

AFib是最常见且治疗不足的心律失常之一，影响全球6000多万人。AFib是一种进行性疾病，通常以阵发性AFib（间歇性出现）开始，并持续发展（持续7天以上不停止）。随着疾病的进展，包括心力衰竭，中风和死亡风险在内的严重并发症的风险增加2-5。。

About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries.

关于美敦力思维。更大胆的行动。我们是美敦力。总部位于爱尔兰戈尔韦的美敦力公司是全球领先的医疗保健技术公司，通过寻找和寻找解决方案，大胆应对人类面临的最具挑战性的健康问题。我们的使命是减轻痛苦，恢复健康，延长生命，我们将150个国家的95000多名充满激情的全球团队团结在一起。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们丰富的知识、永不满足的好奇心以及帮助所有需要帮助的人的愿望，我们提供了创新技术，每秒钟、每小时、每天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn..

随着我们增强洞察力驱动的护理、以人为本的体验以及为我们的世界带来更好的结果，对我们的期望会更高。在我们所做的每件事中，我们都在创造非凡。有关美敦力（纽约证券交易所：MDT）的更多信息，请访问www。Medtronic.com，并在LinkedIn上关注美敦力。。