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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

最新數據顯示小直徑除顫導線美敦力 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 臨床試驗符合安全性和有效性目標;結果在 Heart Rhythm 2024 上公佈,並同時發表於 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.

都柏林和波士頓,2024 年 5 月 17 日/PRNewsWire(在新窗口中打開)/--醫療保健技術領域的全球領導者美敦力集團(紐約證券交易所代碼:MDT)宣佈,在全球除顫與可靠性先導評估(LEADR)關鍵試驗中,其在研OmniaSecure除顫先導藥物達到了其主要安全性和有效性終點,超過了預先設定的績效目標。最新研究結果發表在 Heart Rhythm 2024 上,並同時發表在該期刊上 心律(在新窗口中打開)在全球範圍內, OmniaSecure除顫線索仍在研究中,尚未獲準銷售或分銷。

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).

植入式心律復律除顫器(ICD)是預防心臟性猝死的黃金標準。然而,經靜脈除顫器導線仍然是系統中最薄弱的地方,它們是連接ICD並穿過靜脈穿過心肌肉的細線,1 考慮到人體內部的惡劣環境,患者一生中必須保持導線附着並彎曲,伴隨數百萬次心臟收縮。現有的除顫導管的直徑很大(7-8 法語),這可能導致靜脈閉塞或三尖瓣併發症。對於可能不適合使用血管外除顫器的患者,美敦力工程師根據美敦力SelectSecure Model 3830起搏導線設計了OmniaSecure除顫導線,該起搏導管20多年來一直爲患者提供安全有效的治療。美敦力 OmniaSecure 引線從這種高度可靠的起搏導線開始,再製造更大的適合除顫治療的導線,是世界上最小的經靜脈除顫導線(4.7 法語,相當於木鉛筆中石墨的直徑)。

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名患者植入設備時進行的除顫測試在97.5%的病例中取得了成功。該研究超過了預先設定的88%的療效目標。

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
在六個月時,657名嘗試植入的患者中有97.1%(Kaplan-Meier估計)沒有與鉛相關的主要併發症,例如住院、鉛骨折、系統修復或死亡。該研究超過了預先設定的90%的安全績效目標。在六到十二個月之間,未觀察到與鉛相關的主要併發症(平均隨訪時間爲12.7±4.8個月)。

"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."

田納西州納什維爾範德比爾特大學醫學中心電生理學實驗室和心臟研究企業主任、LEADR Pivotal試驗指導委員會主席喬治·克羅斯利醫學博士說:“LEADR Pivotal試驗的積極結果對於在心律危險的情況下依靠ICD提供挽救生命的心臟性猝死風險患者來說是一項重大進展。”“如今,使用除顫器的患者壽命更長,我們需要努力爲患者終身提供可靠的治療。這種創新、低調的除顫導線利用高度可靠的起搏導線設計來幫助實現這一目標,而獨特的基於導管的植入方法可幫助醫生將導線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試驗是一項前瞻性、多中心、單臂、非隨機的全球臨床研究,旨在評估將美敦力 OmniaSecure 除顫導線放置在右心室的傳統位置以實現心臟性猝死風險的患者進行除顫、感應、起搏和心臟復律時的安全性和有效性。該研究在北美、歐洲、亞洲和澳大利亞17個國家的45個地點招收了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.

次要結果和輔助結果:可靠性
該導線表現出可靠的表現,平均隨訪時間爲12.7±4.8個月,其中零(0)例鉛骨折。美敦力開發並驗證了一種體外模型,該模型可以準確預測長達10年的鉛可靠性,2 然後在研究中應用該模型,預測研究中的OmniaSecure負責人兩年內無骨折存活率爲99.9%。該導線還顯示出97.9%的植入成功率,並且在12個月內保持穩定的電氣信號(R-Wave、起搏捕獲閾值和起搏阻抗)。

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.

研究中將近12%的患者在14.0±5.0個月內接受了針對危險快速心室心律失常的適當治療(休克或抗心動過速起搏 [ATP])。ATP終止了74.9%的發作,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.

美敦力計劃在未來幾個月內公佈來自LEADR研究的更多可靠性模型結果。

"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年來,美敦力一直在創新,爲有需要的患者提供更好的救生技術,” 心律管理業務首席醫學官Alan Cheng醫學博士說,該業務是美敦力心血管產品組合的一部分。“鑑於我們與醫療保健提供者合作爲心律失常患者設計技術的歷史,我們運用我們在經靜脈除顫和起搏導線方面的豐富經驗來創造出新型的OmniaSecure導線,這是一種可以放置在所需位置的導管輸送導線。LEADR的研究結果在實現爲患者提供更可靠的除顫線索的目標方面向前邁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》上公佈的LEADR結果外,美敦力最近啓動了LEADR LBBAP研究(左束分支區域起搏的除顫和可靠性先導評估),該研究正在評估在研的OmniaSecure除顫導聯在左束分支區域對有資格接受ICD或左束支支優化心臟再同步療法(LOT-LOT)的患者的安全性和有效性 CRT)。目前正在評估將除顫導線置於左束分支區域,以替代右心室刺激,進行感應、起搏、心律復律和除顫。最近,俄亥俄州立醫學中心韋克斯納醫學中心首席研究員穆罕默德·阿夫扎爾醫學博士、MBBS和明尼阿波利斯心臟研究所基金會首席研究員約翰·扎凱布醫學博士進行了首次植入。

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).

關於美敦力
大膽思考。更大膽的行動。我們是美敦力。總部位於愛爾蘭都柏林的美敦力集團是全球領先的醫療保健技術公司,通過尋找和尋找解決方案,大膽地應對人類面臨的最具挑戰性的健康問題。我們的使命——減輕痛苦、恢復健康和延長壽命——團結了一支由來自150個國家的95,000多名充滿激情的人組成的全球團隊。我們的技術和療法可治療 70 種健康狀況,包括心臟設備、手術機器人、胰島素泵、手術工具、患者監護系統等。在我們多樣的知識、永不滿足的好奇心以及幫助所有有需要的人的願望的推動下,我們提供創新技術,每秒、每小時、每天都在改變兩個人的生活。隨着我們賦予以洞察爲導向的醫療服務、以人爲本的體驗以及爲我們的世界帶來更好的成果,我們對我們的期望更高。在我們所做的每件事中,我們都在設計非凡的事物。有關美敦力(紐約證券交易所代碼:MDT)的更多信息,請訪問 www.medtronic.com(打開新窗口) 然後關注美敦力 領英(打開新窗口)

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.

任何前瞻性陳述均受風險和不確定性的影響,例如美敦力向美國證券交易委員會提交的定期報告中描述的風險和不確定性。實際結果可能與預期結果存在重大差異。

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。植入式心臟除顫器導線故障和管理。J Am Coll Cardiol 2016;67:1358-1368

2

Wilkoff、Bruce L. 等體外建模可以準確預測10年後的心導骨折。心律 18.9 (2021): 1605-1612。

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