DUBLIN and BOSTON, May 17, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive results demonstrating excellent safety and efficacy of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter for the treatment of persistent atrial fibrillation (AFib).

都柏林和波士顿，2024年5月17日/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）今天宣布了积极的结果，证明了Affera™标测和消融系统与Sphere-9™导管，一种用于治疗持续性心房颤动（AFib）的一体式脉冲场（PF）和射频（RF）消融和高密度（HD）标测导管具有优异的安全性和有效性。

The SPHERE Per-AF study, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial, compared Sphere-9 to the conventional Thermocool SmartTouch® SF radiofrequency ablation catheter with the Carto™ 3 System. Findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting and simultaneously published in Nature Medicine.

SPHERE Per AF研究是美国食品和药物管理局（FDA）的一项研究设备豁免（IDE）关键试验，将SPHERE-9与传统的Thermocool SmartTouch®SF射频消融导管和Carto™3系统进行了比较。研究结果在心律协会（HRS）2024年会上作为最新的临床数据发表，并同时发表在《自然医学》上。

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'These are excellent results for the investigational Sphere-9 catheter. The data show Sphere-9 lattice tip technology enables physicians to create a wide circumferential pulmonary vein isolation, which is the cornerstone of any type of AFib ablation, and any set of desired ablation lesions, in a safe, effective and efficient manner,' said Elad Anter, M.D., Director of the Arrythmia Institute, Shamir Medical Center, Israel.

“这些对于研究性Sphere-9导管来说是极好的结果。以色列沙米尔医学中心心律失常研究所主任Elad Anter医学博士说：“数据显示，Sphere-9点阵尖端技术使医生能够以安全、有效和高效的方式创建广泛的环肺静脉隔离，这是任何类型的AFib消融和任何一组所需消融病变的基石。”。

'Persistent AFib patients make up 30-50% of the patient population and are often challenging to treat, with the majority of procedures requiring additional lesion sets beyond pulmonary vein isolation. The versatility and ease of use of this mapping and ablation system led to impressive efficiency and treatment outcomes in the trial.'.

“持续性AFib患者占患者人群的30-50%，通常难以治疗，大多数手术需要肺静脉隔离以外的额外病变组。这种测绘和消融系统的多功能性和易用性导致了试验中令人印象深刻的效率和治疗结果。”。

The Sphere-9 Catheter demonstrated a positive safety profile with an excellent primary safety endpoint rate of 1.4% (1.0% for the control arm). Importantly, no safety events including pulmonary vein stenosis, esophageal events or cardiac tamponade were reported. More than 95% of Sphere-9 procedures used a single transeptal puncture compared to 62% in the control arm.Sphere-9 demonstrated 73.8% freedom from AFib* vs.

Sphere-9导管表现出积极的安全性，主要安全终点率为1.4%（对照组为1.0%）。重要的是，没有报道包括肺静脉狭窄，食管事件或心脏压塞在内的安全事件。超过95%的Sphere-9手术使用单次经腹穿刺，而对照组为62%。Sphere-9显示出73.8%的AFib*自由度。

only 65.8% observed in the control arm. Following 100% acute isolation of pulmonary veins and linear lesions, patients treated with the Sphere-9 Catheter also observed less recurrence of atrial arrhythmias throughout the 12-month follow up period.Treatment with the Sphere-9 catheter demonstrated superior efficiency over the control arm for procedural characteristics including:Skin-to-skin procedural timeTime between first and last ablationEnergy application timePatients treated with the Sphere-9 catheter experienced improvements to quality of life in both mental and physical well-being.'As pioneers in cardiac ablation treatment, including cryoablation and PFA, we are thrilled to share these results providing excellent evidence for use of this all-in-one catheter that can be used with no need to pull a second catheter,' said Rebecca Seidel, president, Cardiac Ablations Solutions business, which is part of the Cardiovascular Portfolio at Medtronic.

在对照组中仅观察到65.8%。在100%急性隔离肺静脉和线性病变后，用Sphere-9导管治疗的患者在整个12个月的随访期间也观察到房性心律失常的复发较少。Sphere-9导管治疗在程序特征方面比对照组表现出更高的效率，包括：第一次和最后一次消融之间的皮肤到皮肤程序时间能量应用时间Sphere-9导管治疗的患者在精神和身体健康方面的生活质量都有所改善。”作为包括冷冻消融和PFA在内的心脏消融治疗的先驱，我们很高兴分享这些结果，为使用这种多功能导管提供了极好的证据，无需拔第二根导管即可使用，”美敦力心血管投资组合的心脏消融解决方案业务总裁丽贝卡·塞德尔（RebeccaSeidel）说。

'The Affera Mapping and Ablation system with Sphere-9 Catheter demonstrates a positive safety, efficacy and efficiency profile and can amplify our innovative and trusted portfolio. With these results, we are now one step closer to bringing this technology to the U.S. and beyond.'.

“带有Sphere-9导管的Affera标测和消融系统显示出积极的安全性，有效性和效率，可以扩大我们创新和值得信赖的投资组合。有了这些结果，我们现在离将这项技术带到美国乃至世界更近了一步。”。

SPHERE Per-AF was a prospective, multicenter, randomized clinical trial evaluating the Sphere-9 Catheter with the Affera Mapping and Ablation System for treatment of persistent AFib. Subjects were randomized 1:1 to receive treatment with either the Sphere-9 Catheter with the Affera Mapping and Ablation System or the Thermocool SmartTouch® SF radiofrequency ablation catheter with the Carto™ 3 System.

SPHERE Per AF是一项前瞻性，多中心，随机临床试验，评估SPHERE-9导管与Affera标测和消融系统治疗持续性AFib。受试者以1:1的比例随机接受带有Affera标测和消融系统的Sphere-9导管或带有Carto™3系统的Thermocool SmartTouch®SF射频消融导管的治疗。

For the primary analysis, a total of 420 patients were enrolled across 23 sites in three countries: the United States, Czech Republic and Israel. All patients in both arms of the trial received pulmonary vein isolation as well as linear lesions based on the patient's needs..

对于初步分析，在美国，捷克共和国和以色列三个国家的23个地点共招募了420名患者。根据患者的需要，试验两臂的所有患者均接受了肺静脉隔离以及线性病变。。

Affera Sphere-9 features include:

Affera Sphere-9的功能包括：

All-in-one HD mapping and ablation catheter fully integrated with the Affera Mapping and Ablation System9mm lattice tip with large footprintConvenience of dual energy, pulsed field or radiofrequency'We've been waiting for one catheter that can be used for every arrhythmia, and these randomized results from centers that routinely use conventional point by point ablation indicate Affera Sphere-9 will be worth the wait with all its innovation and the rapid learning curve of the system,' said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City.

多功能高清标测和消融导管与Affera标测和消融系统完全集成9mm点阵尖端，具有大的足迹双能量，脉冲场或射频的便利性。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，我们一直在等待一种可用于每种心律失常的导管，这些来自常规逐点消融中心的随机结果表明，Affera Sphere-9凭借其所有创新和系统的快速学习曲线，值得等待。

'These are important, highly anticipated results and groundbreaking news for the electrophysiology community that could change the treatment workflow.'.

“这些对于电生理学界来说是重要的，备受期待的结果和开创性的消息，可能会改变治疗工作流程。”。

The company recently filed for approval of the Affera Sphere-9 Catheter in the U.S. with the FDA. The Affera Sphere-9 Catheter is investigational in the United States and not approved for sale or distribution. The Affera Mapping and Ablation System, which includes the Sphere-9 Catheter, received CE Mark approval in March 2023..

该公司最近在美国向FDA申请批准Affera Sphere-9导管。Affera Sphere-9导管在美国进行研究，未被批准销售或分销。包括Sphere-9导管在内的Affera标测和消融系统于2023年3月获得CE标志批准。。

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。。

For more information on Affera SPHERE-9, visit Medtronic.com.

有关Affera SPHERE-9的更多信息，请访问Medtronic.com。

*The primary effectiveness endpoint was a composite of freedom from: failure to isolate all targeted pulmonary veins and complete all left atrial ablation with the assigned study device; repeat ablation at any time after the index procedure; and after a 3-month blanking period, documented occurrence of atrial tachyarrhythmia, escalation or initiation of Class I or III antiarrhythmic drugs, or cardioversion..

*主要有效性终点是自由的组合：未能隔离所有靶向肺静脉并用指定的研究装置完成所有左心房消融；在索引程序后的任何时间重复消融；经过3个月的消隐期后，记录了房性快速性心律失常的发生，I类或III类抗心律失常药物的升级或开始，或复律。。

About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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。总部位于爱尔兰都柏林的美敦力公司（Medtronic plc）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。