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美敦力多器官SPYRAL GEMINI先导研究中首位患者接受治疗

First patient treated in Medtronic multi-organ SPYRAL GEMINI Pilot study

美敦力 等信源发布 2025-07-07 23:04

可切换为仅中文


Medtronic advances pipeline with update on multi-organ denervation study and additional data recently presented at EuroPCR 2025

美敦力公司在2025年EuroPCR上更新了多器官去神经研究的进展,并发布了更多数据。

Medtronic, a global leader in healthcare technology, today announced that it has treated the first patient in its SPYRAL GEMINI Pilot program (including 'OFF MED’ and 'ON MED’ studies).

美敦力,全球医疗技术的领导者,今天宣布其SPYRAL GEMINI试点项目(包括“OFF MED”和“ON MED”研究)已治疗了首位患者。

The first patient was treated by Dr. Barry Bertolet at Cardiology Associates of North Mississippi and North Mississippi Medical Center in Tupelo. With this trial, Medtronic intends to investigate the feasibility of combined denervation of both the renal and common hepatic (liver) arteries with the Symplicity Spyral™ catheter.

第一位患者由巴里·贝托莱特医生在密西西比州北部的北密西西比心脏病学协会和北密西西比医疗中心(位于图佩洛)进行治疗。通过这项试验,美敦力公司旨在研究使用Symplicity Spyral™导管对肾动脉和肝总动脉(肝脏动脉)进行联合去神经支配的可行性。

The planned .

计划中的。

lobal Pilot study of r

全球试点研究

ed denervat

去神经的

on (SPYRAL GEMINI Pilot study) will investigate the safety and potential efficacy of the multi-organ denervation (MDN) approach in uncontrolled hypertension patients who are both on and off medications.

关于(SPYRAL GEMINI 试点研究)将调查多器官去神经(MDN)方法在使用和未使用药物的失控高血压患者中的安全性和潜在疗效。

“In addition to denervation of the renal arteries - where the blood pressure lowering clinical benefit has already been established through multiple rigorously designed clinical trials - targeting other richly innervated vascular areas such as the common hepatic artery is an emerging horizon for treating hypertension,” said Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL GEMINI pilot study.

“除了肾动脉去神经支配(通过多项严格设计的临床试验已经证实其降血压的临床益处)之外,针对其他神经丰富的血管区域(如肝总动脉)是一个治疗高血压的新方向,”皮德蒙特心脏研究所和心血管服务部首席专家、SPYRAL GEMINI试点研究的首席研究员大卫·坎达里博士表示。

“We look forward to learning more about the potential efficacy of denervation in both the liver and renal arteries from SPYRAL GEMINI.”.

“我们期待从SPYRAL GEMINI中了解更多关于去神经支配在肝动脉和肾动脉中的潜在疗效。”

The SPYRAL GEMINI Pilot study is a prospective, multicenter, international, feasibility study in two parallel cohorts of hypertensive patients, including patients off anti-hypertensive medications and patients with high cardiovascular risk who are taking anti-hypertensive medications. The program will enroll up to 175 patients in the United States, Europe and Australia.

SPYRAL GEMINI Pilot 研究是一项前瞻性、多中心、国际性的可行性研究,针对两个平行的高血压患者队列,包括未服用抗高血压药物的患者和正在服用抗高血压药物的高心血管风险患者。该项目将在美国、欧洲和澳大利亚招募多达 175 名患者。

Denervation will occur in both the common hepatic and main renal arteries and branches using the Symplicity Spyral catheter. Procedural safety and efficacy will both be evaluated starting at three months and continuing through 36 months post-procedure..

使用Symplicity Spyral导管将在肝总动脉、肾主动脉及其分支中进行去神经术。手术的安全性和有效性将从术后三个月开始评估,并持续到术后36个月。

“As a pioneer in renal denervation, Medtronic is uniquely positioned to explore the clinical potential of multi-organ denervation with Symplicity Spyral’s low profile and single catheter design, and intellectual property in this field,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular portfolio at Medtronic.

“作为肾去神经领域的先驱,美敦力凭借Symplicity Spyral的低剖面和单导管设计以及在该领域的知识产权,具备独特的优势来探索多器官去神经的临床潜力,”美敦力心血管产品组合中冠状动脉与肾去神经业务的高级副总裁兼总裁Jason Weidman表示。

“As a company, Medtronic is committed to investing in strategically important areas that hold promise for patients and the medical community.'.

“作为一家公司,美敦力致力于投资于对患者和医学界有希望的战略重要领域。”

Recently presented EuroPCR 2025 preclinical data showed a 90% significant reduction in norepinephrine (marker of sympathetic activity) with multiorgan denervation.

近日公布的2025年欧洲经皮心血管介入会议(EuroPCR)临床前数据显示,多器官去神经支配使去甲肾上腺素(交感神经活动标志物)显著减少了90%。

These findings suggest that multiorgan denervation using the Spyral system can successfully denervate within both the hepatic and renal arteries.

这些研究结果表明,使用Spyral系统的多器官去神经可以成功地在肝动脉和肾动脉内实现去神经。

Hepatic denervation is limited by law to clinical investigation in all geographies. The generator and catheter used in the SPYRAL GEMINI Pilot study for hepatic denervation are not approved for sale or use in the U.S. or any other country.

肝去神经术在所有地区都受法律限制仅用于临床研究。在SPYRAL GEMINI试点研究中用于肝去神经术的发电机和导管未获准在美国或其他任何国家销售或使用。

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 more than 150 countries.

大胆思考。更大胆的行动。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,勇敢地应对人类面临的最严峻的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——团结了遍布150多个国家的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、患者监测系统等。凭借我们多样化的知识、无尽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 .

期待我们带来更多成果,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结果。在我们所做的一切中,我们正在创造非凡的工程。欲了解有关美敦力的更多信息,请访问。