Medtronic plc, a global leader in healthcare technology, today announced approval from the United States Food and Drug Administration (FDA) to conduct an early feasibility study to evaluate the Affera™ Mapping and Ablation System with Sphere-9™ Catheter for treatment of sustained ventricular tachycardia (VT).

医疗保健技术的全球领导者美敦力公司今天宣布，美国食品和药物管理局（FDA）批准进行早期可行性研究，以评估带有Sphere-9™导管的Affera™标测和消融系统，用于治疗持续性室性心动过速（VT）。

VT is a potentially life-threatening abnormal heart rhythm affecting the lower chamber of the heart..

VT是一种潜在的危及生命的异常心律，会影响心脏的下腔。。

The Affera Mapping and Ablation System with Sphere-9 Catheter is an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-density mapping catheterfor use in cardiac electrophysiology ablation procedures.

带有Sphere-9导管的Affera标测和消融系统是一种多功能，双能量脉冲场（PF）和射频（RF）消融以及高密度标测导管，用于心脏电生理消融程序。

“Physicians need better tools to treat VT safely and effectively,and early feasibility research is a positive step toward determining potential new options,” said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. “I am pleased to be involvedin the study and look forward to getting started.”.

“医生需要更好的工具来安全有效地治疗室速，早期的可行性研究是确定潜在新选择的积极步骤，”纽约市西奈山卫生系统心律失常服务主任维韦克·雷迪医学博士说。“我很高兴参与这项研究，并期待着开始。”。

The study will evaluate ablation treatment with Sphere-9 and the Affera system for patients who suffer from VT due to scarring from a prior myocardial infarction (heart attack). Primary endpoints include rate of device- or procedure-related serious adverse events (SAEs) following the ablation procedure and acute effectiveness at ablating the targeted VT. Patients enrolled at centers across the United States will be followed for six months post-ablation..

该研究将评估Sphere-9和Affera系统对因先前心肌梗死（心脏病发作）瘢痕形成而患有VT的患者的消融治疗。主要终点包括消融手术后器械或手术相关严重不良事件（SAE）的发生率以及消融目标VT的急性有效性。在美国各地的中心登记的患者将在消融后6个月内接受随访。。

“We look forward to learning more about how the Sphere-9Catheter, which offers physicians the ability to map and ablatewith the option of choosing PF or RF, together with a large lattice-tip for managing the large target areas for ablation that typically present with VT, can be a useful tool for this challenging arrythmia,” said Khaldoun Tarakji, M.D., MPH,vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “Currently approved treatments for VT involve only RF energy and require physicians to use multiple mapping and ablation catheters with often long, inefficient procedure times.PFA technology and the innovative Sphere-9 design could have a significant impact on patient care.”.

美敦力心血管投资组合的心脏消融解决方案业务副总裁兼首席医疗官、医学博士Khaldoun Tarakji说：“我们期待着更多地了解Sphere-9Catheter如何成为治疗这种具有挑战性的心律失常的有用工具，Sphere-9Catheter可以为医生提供映射和消融的能力，可以选择PF或RF，以及用于管理VT通常存在的消融大目标区域的大型晶格尖端。”。“目前批准的VT治疗仅涉及射频能量，要求医生使用多个标测和消融导管，通常手术时间长，效率低。PFA技术和创新的Sphere-9设计可能会对患者护理产生重大影响。”。

The early feasibility study will build on promising preclinical evidence in VT as well as extensive research demonstrating the efficacy and safety of Sphere-9 for treatment of persistent atrial fibrillation (Afib), another form of arrythmia. Sphere-9 received CE Mark in 2023 for treatment of persistent Afib and is investigational in the U.S..

早期可行性研究将建立在VT的有希望的临床前证据以及广泛的研究基础上，证明Sphere-9治疗另一种心律失常形式持续性心房颤动（Afib）的有效性和安全性。Sphere-9于2023年获得CE标志，用于治疗持续性Afib，并正在美国进行研究。。

VT is a potentially life-threatening arrythmia that causes the heart to beat abnormally fast.1 Unlike AFib, VT affects the lower chamber of the heart and often presents after a heart attack or together with other advanced heart disease.1,2 As a result, VT patients are treated with medications and often receive life-saving therapies from implanted defibrillators in the form of pacing or shocks.1 Catheter ablation for VT is an establishedtreatment option; however, outcomes have remained suboptimal2with little ablation tool innovation in recent years.

VT是一种潜在的危及生命的心律失常，会导致心脏异常快速跳动[1]。与AFib不同，VT会影响心脏的下腔，通常在心脏病发作后或与其他晚期心脏病一起出现[1,2]。因此，VT患者接受药物治疗，并常以起搏或电击的形式接受植入式除颤器的救生治疗[1]。VT导管消融是一种既定的治疗选择；然而，近年来，消融工具创新很少，结果仍然不理想2。

As a result, a significant unmet need exists to improve patient care.3.

因此，存在改善患者护理的重大未满足需求。

About Medtronic

关于美敦力

Bold 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.

大胆思考。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，延长寿命，我们团结了150个国家的95000多名充满激情的全球团队。

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.

。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, 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。有关美敦力的更多信息，请访问www。美敦力，并在LinkedIn上关注美敦力。。