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Late-breaking Data Show Reliable Performance of Small-diameter Defibrillation Lead, the Medtronic OmniaSecure

Late-breaking Data Show Reliable Performance of Small-diameter Defibrillation Lead, the Medtronic OmniaSecure

最新数据显示小直径除颤导线美敦力 OmniaSecure 性能可靠
美敦力 ·  05/17 12:00

Global LEADR clinical trial meets safety and effectiveness objectives; results presented at Heart Rhythm 2024 and simultaneously published in Heart Rhythm

Global LEADR 临床试验符合安全性和有效性目标;结果在 Heart Rhythm 2024 上公布,并同时发表于 心律

DUBLIN and BOSTON, May 17, 2024 /PRNewswire(opens new window)/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced that its investigational OmniaSecure defibrillation lead met its primary safety and effectiveness endpoints, exceeding prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial. Late breaking results were presented at Heart Rhythm 2024 and simultaneously published in the journal Heart Rhythm(opens new window). Worldwide, the OmniaSecure defibrillation lead is investigational and not yet approved for sale or distribution.

都柏林和波士顿,2024 年 5 月 17 日/PRNewsWire(在新窗口中打开)/--医疗保健技术领域的全球领导者美敦力集团(纽约证券交易所代码:MDT)宣布,在全球除颤与可靠性先导评估(LEADR)关键试验中,其在研OmniaSecure除颤先导药物达到了其主要安全性和有效性终点,超过了预先设定的绩效目标。最新研究结果发表在 Heart Rhythm 2024 上,并同时发表在该期刊上 心律(在新窗口中打开)在全球范围内, OmniaSecure除颤线索仍在研究中,尚未获准销售或分销。

Implantable cardioverter defibrillators (ICDs) are the gold standard for preventing sudden cardiac death. Yet transvenous defibrillator leads, which are thin wires connected to the ICD and threaded through the veins into the heart muscle, remain the weakest point of the system,1 given the harsh environment inside the human body where the lead must remain attached and yet flex with millions of heart contractions over a patient's lifetime. Existing defibrillation leads have a large diameter (7-8 French), which can contribute to venous occlusion or tricuspid valve complications. For patients where an extravascular defibrillator may not be appropriate, Medtronic engineers designed the OmniaSecure defibrillation lead based on the Medtronic SelectSecure Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years. By beginning with this highly reliable pacing lead and building a larger lead suitable for defibrillation therapy, the Medtronic OmniaSecure lead is the world's smallest transvenous defibrillation lead (4.7 French, equivalent to the diameter of graphite in a wooden pencil).

植入式心律复律除颤器(ICD)是预防心脏性猝死的黄金标准。然而,经静脉除颤器导线仍然是系统中最薄弱的地方,它们是连接ICD并穿过静脉穿过心肌肉的细线,1 考虑到人体内部的恶劣环境,患者一生中必须保持导线附着并弯曲,伴随数百万次心脏收缩。现有的除颤导管的直径很大(7-8 法语),这可能导致静脉闭塞或三尖瓣并发症。对于可能不适合使用血管外除颤器的患者,美敦力工程师根据美敦力SelectSecure Model 3830起搏导线设计了OmniaSecure除颤导线,该起搏导管20多年来一直为患者提供安全有效的治疗。美敦力 OmniaSecure 引线从这种高度可靠的起搏导线开始,再制造更大的适合除颤治疗的导线,是世界上最小的经静脉除颤导线(4.7 法语,相当于木铅笔中石墨的直径)。

LEADR Primary Results: Effectiveness
Defibrillation testing conducted at device implantation in 119 patients was successful in 97.5% of cases. The study exceeded the prespecified efficacy goal of 88%.

LEADR 主要成果:有效性
在119名患者植入设备时进行的除颤测试在97.5%的病例中取得了成功。该研究超过了预先设定的88%的疗效目标。

LEADR Primary Results: Safety
At six months, 97.1% (Kaplan-Meier estimate) of 657 patients with an implant attempt were free from lead-related major complications such as hospitalization, lead fracture, system revision, or death. The study exceeded the prespecified safety performance goal of 90%. There were no lead-related major complications observed between six and 12 months (average follow up of 12.7±4.8 months).

LEADR 主要成果:安全
在六个月时,657名尝试植入的患者中有97.1%(Kaplan-Meier估计)没有与铅相关的主要并发症,例如住院、铅骨折、系统修复或死亡。该研究超过了预先设定的90%的安全绩效目标。在六到十二个月之间,未观察到与铅相关的主要并发症(平均随访时间为12.7±4.8个月)。

"The positive results from the LEADR Pivotal trial are a significant advancement for patients at risk of sudden cardiac death who rely on ICDs to deliver life-saving therapy in the event of a dangerous heart rhythm," said George H. Crossley, M.D., Director of the Electrophysiology Lab and Cardiac Research Enterprise, Vanderbilt University Medical Center, Nashville, Tenn., and LEADR Pivotal trial steering committee chair. "Patients with defibrillators are living longer today, and we need to strive for reliable therapy for the lifetime of the patient. This innovative, low-profile defibrillation lead leverages a highly reliable pacing lead design to help achieve this goal, and the unique catheter-based method of implantation helps the physician place the lead in the optimal position for the patient."

田纳西州纳什维尔范德比尔特大学医学中心电生理学实验室和心脏研究企业主任、LEADR Pivotal试验指导委员会主席乔治·克罗斯利医学博士说:“LEADR Pivotal试验的积极结果对于在心律危险的情况下依靠ICD提供挽救生命的心脏性猝死风险患者来说是一项重大进展。”“如今,使用除颤器的患者寿命更长,我们需要努力为患者终身提供可靠的治疗。这种创新、低调的除颤导线利用高度可靠的起搏导线设计来帮助实现这一目标,而独特的基于导管的植入方法可帮助医生将导线放置在患者的最佳位置。”

The LEADR Pivotal trial is a prospective, multicenter, single-arm, non-randomized, global clinical study that assessed the safety and effectiveness of the Medtronic OmniaSecure defibrillation lead when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac death. The study enrolled 675 patients at 45 sites in 17 countries in North America, Europe, Asia, and Australia.

LEADR Pivotal试验是一项前瞻性、多中心、单臂、非随机的全球临床研究,旨在评估将美敦力 OmniaSecure 除颤导线放置在右心室的传统位置以实现心脏性猝死风险的患者进行除颤、感应、起搏和心脏复律时的安全性和有效性。该研究在北美、欧洲、亚洲和澳大利亚17个国家的45个地点招收了675名患者。

Secondary and Ancillary Results: Reliability
The lead demonstrated reliable performance with zero (0) study lead fractures through an average follow up of 12.7±4.8 months. Medtronic developed and validated an in-vitro model that accurately predicts lead reliability out to 10 years,2 and then applied that model within the study to predict a fracture-free survival of 99.9% at two years for the investigational OmniaSecure lead. The lead also demonstrated a 97.9% implant success rate, and stable electricals (R-wave, pacing capture threshold, and pacing impedance) through 12 months.

次要结果和辅助结果:可靠性
该导线表现出可靠的表现,平均随访时间为12.7±4.8个月,其中零(0)例铅骨折。美敦力开发并验证了一种体外模型,该模型可以准确预测长达10年的铅可靠性,2 然后在研究中应用该模型,预测研究中的OmniaSecure负责人两年内无骨折存活率为99.9%。该导线还显示出97.9%的植入成功率,并且在12个月内保持稳定的电气信号(R-Wave、起搏捕获阈值和起搏阻抗)。

Nearly 12% of patients in the study received appropriate therapy (shock, or anti-tachycardia pacing [ATP]) for dangerously fast ventricular arrhythmias by 14.0±5.0 months. ATP terminated 74.9% of episodes, preventing a shock in 49 patients.

研究中将近12%的患者在14.0±5.0个月内接受了针对危险快速心室心律失常的适当治疗(休克或抗心动过速起搏 [ATP])。ATP终止了74.9%的发作,防止了49名患者的休克。

Medtronic plans to present additional reliability model results from the LEADR study in the coming months.

美敦力计划在未来几个月内公布来自LEADR研究的更多可靠性模型结果。

"For 75 years, Medtronic has innovated to bring better life-saving technologies to the patients who need them," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "Given our history in working with health care providers to design technology for patients with arrhythmias, we applied learnings from our deep experience with both transvenous defibrillation and pacing leads to create the novel OmniaSecure lead, a catheter-delivered lead that can be placed in the desired location. The LEADR study results are an encouraging step forward in achieving the goal of an even more reliable defibrillation lead for patients."

“75年来,美敦力一直在创新,为有需要的患者提供更好的救生技术,” 心律管理业务首席医学官Alan Cheng医学博士说,该业务是美敦力心血管产品组合的一部分。“鉴于我们与医疗保健提供者合作为心律失常患者设计技术的历史,我们运用我们在经静脉除颤和起搏导线方面的丰富经验来创造出新型的OmniaSecure导线,这是一种可以放置在所需位置的导管输送导线。LEADR的研究结果在实现为患者提供更可靠的除颤线索的目标方面向前迈出了令人鼓舞的一步。”

In addition to the LEADR results presented at Heart Rhythm 2024, Medtronic recently initiated the LEADR LBBAP study (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing), which is assessing the safety and efficacy of the investigational OmniaSecure defibrillation lead when placed at the Left Bundle Branch Area in patients eligible for an ICD or Left Bundle Branch-Optimized Cardiac Resynchronization Therapy (LOT-CRT). Placing the defibrillation lead in the left bundle branch area is being evaluated as an alternative to right ventricular stimulation for sensing, pacing, cardioversion and defibrillation. First implants were recently conducted by Muhammad Afzal, M.D., MBBS, principal investigator at The Ohio State Medical Center Wexner Medical Center, and John Zakaib, M.D., principal investigator at Minneapolis Heart Institute Foundation.

除了在《Heart Rhythm 2024》上公布的LEADR结果外,美敦力最近启动了LEADR LBBAP研究(左束分支区域起搏的除颤和可靠性先导评估),该研究正在评估在研的OmniaSecure除颤导联在左束分支区域对有资格接受ICD或左束支支优化心脏再同步疗法(LOT-LOT)的患者的安全性和有效性 CRT)。目前正在评估将除颤导线置于左束分支区域,以替代右心室刺激,进行感应、起搏、心律复律和除颤。最近,俄亥俄州立医学中心韦克斯纳医学中心首席研究员穆罕默德·阿夫扎尔医学博士、MBBS和明尼阿波利斯心脏研究所基金会首席研究员约翰·扎凯布医学博士进行了首次植入。

About Medtronic
Bold 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. 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. 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(opens new window) and follow Medtronic on LinkedIn(opens new window).

关于美敦力
大胆思考。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集团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,大胆地应对人类面临的最具挑战性的健康问题。我们的使命——减轻痛苦、恢复健康和延长寿命——团结了一支由来自150个国家的95,000多名充满激情的人组成的全球团队。我们的技术和疗法可治疗 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、患者监护系统等。在我们多样的知识、永不满足的好奇心以及帮助所有有需要的人的愿望的推动下,我们提供创新技术,每秒、每小时、每天都在改变两个人的生活。随着我们赋予以洞察为导向的医疗服务、以人为本的体验以及为我们的世界带来更好的成果,我们对我们的期望更高。在我们所做的每件事中,我们都在设计非凡的事物。有关美敦力(纽约证券交易所代码:MDT)的更多信息,请访问 www.medtronic.com(打开新窗口) 然后关注美敦力 领英(打开新窗口)

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

任何前瞻性陈述均受风险和不确定性的影响,例如美敦力向美国证券交易委员会提交的定期报告中描述的风险和不确定性。实际结果可能与预期结果存在重大差异。

1

Swerdlow CD, Kalahasty G, Ellenbogen KA. Implantable Cardiac Defibrillator Lead Failure and Management. J Am Coll Cardiol 2016;67:1358-1368

2

Wilkoff, Bruce L., et al. In vitro modeling accurately predicts cardiac lead fracture at 10 years. Heart Rhythm 18.9 (2021): 1605-1612.

1

Swerdlow CD、Kalahasty G、Ellenbogen KA。植入式心脏除颤器导线故障和管理。J Am Coll Cardiol 2016;67:1358-1368

2

Wilkoff、Bruce L. 等体外建模可以准确预测10年后的心导骨折。心律 18.9 (2021): 1605-1612。

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