Findings highlight the potential of new investigational waveforms for the all-in-one mapping and dual-energy ablation system in advancing treatment for ventricular arrhythmia patients

研究结果突显了新型研究波形在一体化标测和双能量消融系统中推动室性心律失常患者治疗的潜力。

Medtronic plc, a global leader in healthcare technology, today announced promising results, including a 100% acute procedural success rate, from an early feasibility study of the Sphere-9™ Catheter with Affera™ Mapping and Ablation System for treatment of sustained ventricular tachycardia (VT). Results were presented as a late breaking clinical trial at the 20.

美敦力公司（Medtronic plc），一家全球领先的医疗技术公司，今天宣布了一项早期可行性研究的可喜结果，该研究涉及使用Sphere-9™导管与Affera™标测和消融系统治疗持续性室性心动过速（VT），结果显示急性手术成功率达到100%。研究结果在20日作为最新临床试验成果发布。

Annual VT Symposium in Philadelphia.

费城年度VT研讨会。

VT is a potentially life-threatening arrhythmia that causes the heart to beat abnormally fast.

室性心动过速是一种可能危及生命的快速心律失常，会导致心脏跳动异常快速。

Unlike atrial fibrillation (AFib), VT affects the lower chamber of the heart and often presents after a heart attack or together with other advanced heart disease.

与心房颤动 (AFib) 不同，室性心动过速 (VT) 影响心脏的下腔，并且通常在心脏病发作后或与其他晚期心脏病一起出现。

“These results, including the excellent overall procedural success rate for eliminating VT, are an encouraging step toward an IDE pivotal trial for this underserved patient population,” said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City.

“这些结果，包括消除室性心动过速的总体手术成功率极高，是针对这一服务不足的患者群体进行IDE关键试验的鼓舞人心的一步，”纽约市西奈山卫生系统心脏心律失常服务主任维韦克·雷迪博士表示。

“I look forward to the continued evaluation of Sphere-9 for VT patients.”.

“我期待对 Sphere-9 在室性心动过速患者中的持续评估。”

The study evaluated catheter ablation treatment with Sphere-9 and the Affera system using new investigational RF and PF waveforms for patients who suffer from VT due to scarring from a prior heart attack. A total of 20 patients treated at centers across the United States are being followed for six months post-ablation.

该研究评估了使用 Sphere-9 和 Affera 系统结合新型射频（RF）和脉冲场（PF）波形进行导管消融治疗，针对因先前心脏病发作导致疤痕而患有室性心动过速（VT）的患者。研究总共招募了美国各地中心的 20 名患者，并在消融手术后对其进行为期六个月的随访。

Key acute findings include:.

关键的急性发现包括：。

100% acute procedural success, defined as non-inducibility of clinically relevant VT at the end of the procedure.

100%的急性手术成功，定义为在手术结束时无法诱发有临床意义的室速（VT）。

A combination of RF and PF energy was used for 95% of patients, with one patient receiving RF only.

95%的患者使用了射频（RF）和脉冲场（PF）能量的组合，其中一名患者仅接受射频（RF）治疗。

The mean procedural time was 198.4±57.9 minutes, with a Sphere-9 catheter dwell time of 153.7±57.4 minutes.

手术平均时间为198.4±57.9分钟，其中Sphere-9导管停留时间为153.7±57.4分钟。

One primary safety event was reported, with symptoms resolving to baseline.

报告了一起主要的安全事件，症状已恢复到基线水平。

VT patients are treated with medications and often receive life-saving therapies from implanted defibrillators in the form of pacing or shocks.

室性心动过速患者通过药物进行治疗，通常会接受植入式除颤器提供的起搏或电击形式的挽救生命的疗法。

Catheter ablation for VT is an established treatment option; however, outcomes have remained suboptimal

导管消融治疗室性心动过速（VT）是一种已确立的治疗选择；然而，其结果仍然不尽如人意。

with little ablation tool innovation in recent years. As a result, a significant unmet need exists to improve patient care.

近年来，消融工具的创新较少。因此，改善患者护理方面存在显著的未满足需求。

'The Sphere-9 catheter, with its large footprint focal design, enhanced stability, integrated mapping and ablation capability in a single catheter, and dual-energy flexibility, introduces multiple innovations aimed at addressing key unmet needs in VT ablation,” said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic.

“Sphere-9 导管凭借其大覆盖范围的焦点设计、增强的稳定性、单一导管中的集成标测和消融能力以及双能量灵活性，引入了多项创新，旨在解决 VT 消融中关键的未满足需求，”美敦力心血管产品组合中心脏消融解决方案业务的副总裁兼首席医疗官 Khaldoun Tarakji 医学博士表示。

“We are committed to advancing catheter ablation innovation across all cardiac arrhythmias, including complex ventricular arrhythmias for which new treatment options have long been awaited.'.

“我们致力于推进所有心律失常的导管消融创新，包括长期以来期待新治疗选择的复杂室性心律失常。”

The Affera Mapping and Ablation System and Sphere-9 catheter received U.S. Food and Drug Administration (FDA) approval in 2024 for treatment of persistent Afib.

Affera标测与消融系统以及Sphere-9导管在2024年获得美国食品药品监督管理局（FDA）批准，用于治疗持续性房颤。

About Medtronic

美敦力公司简介

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。更有力的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找并发现解决方案，大胆攻克人类面临的最严峻健康问题。我们的使命——减轻病痛、恢复健康、延长生命——团结了遍布150个国家的95,000多名充满热情的员工。

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。凭借我们广泛的知识、永无止境的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一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 .

对我们有更多期待，因为我们致力于推动以洞察力为导向的护理、以人为本的体验，以及为我们的世界带来更好的成果。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力的更多信息，请访问。