Medtronic, the global leader in health care technology, today announced the primary and secondary outcomes of the VenaSeal Spectrum Venous Leg Ulcer (VLU) Study in a podium-first presentation at the 2025 Charing Cross International Symposium.

美敦力，这家医疗技术的全球领导者，今天在2025年查令十字国际研讨会上首次以讲台报告的形式公布了VenaSeal光谱静脉腿部溃疡（VLU）研究的主要和次要结果。

This single-arm study prospectively assessed time to ulcer healing following VenaSeal™ treatment in patients with an active venous leg ulcer (classified as C6), as the primary endpoint, and a secondary endpoint of vein closure through 12 months. Results from the Spectrum VLU Study provide essential evidence that VenaSeal effectively heals venous leg ulcers, the most advanced stage of superficial venous insufficiency (SVI), by treating patients at the source of their disease..

这项单臂研究前瞻性地评估了接受VenaSeal™治疗的活动性静脉性腿部溃疡（分类为C6）患者的溃疡愈合时间作为主要终点，并将12个月内的静脉闭合作为次要终点。Spectrum VLU研究的结果提供了重要的证据，证明VenaSeal通过针对患者疾病源头进行治疗，能有效治愈静脉性腿部溃疡，这是浅表静脉功能不全（SVI）的最严重阶段。

“This rigorous clinical data demonstrates that VenaSeal delivers outstanding ulcer healing rates in a challenging subset of patients with advanced superficial venous disease,” said Prof. Manj Gohel, principal investigator of the VenaSeal Spectrum Program, consultant vascular surgeon and honorary senior lecturer, Cambridge University Hospitals, Imperial College (Cambridge, U.K.).“The evidence should give physicians confidence that VenaSeal is an effective, safe, and appropriate treatment for a range of patients experiencing SVI.”.

“这项严格的临床数据表明，VenaSeal 在患有晚期浅表静脉疾病的复杂患者子集中表现出卓越的溃疡愈合率，” VenaSeal Spectrum 项目首席研究员、剑桥大学医院和帝国理工学院（英国剑桥）的血管外科顾问医师兼荣誉高级讲师 Manj Gohel 教授说道。“这些证据应该让医生们相信，VenaSeal 是一种有效、安全且适用于一系列经历浅静脉功能不全（SVI）患者的治疗方案。”

The Spectrum VLU data directly addresses SVI treatment in an understudied, complex patient population. Several factors make C6 patients more complex to treat, including being of advanced chronological age and having high rates of serious comorbidities. This new data builds on the known efficacy of endovenous interventions for less severe superficial venous disease (C2-C5).

Spectrum VLU 数据直接针对一个研究不足且复杂的患者群体的 SVI 治疗。C6 患者更难以治疗的几个因素包括年龄较大和严重合并症发生率较高。这一新数据建立在已知的静脉内介入治疗较轻度浅静脉疾病（C2-C5）的有效性基础之上。

, by demonstrating the value proposition for VenaSeal in the most complex VLU cases.

，通过在最复杂的VLU病例中展示VenaSeal的价值主张。

Healing potential

治愈潜力

VenaSeal delivered strong healing rates, rapid closure, and freedom from ulcer recurrence​.

VenaSeal提供了强大的愈合率、快速闭合并防止溃疡复发。

81.3% ulcer healing rate (1 yr)

81.3% 的溃疡愈合率（1 年）

82.7% anatomic closure rate (1 yr)

82.7% 解剖闭合率（1 年）

83.0% freedom from ulcer recurrence (1 yr, after healing has occurred) ​

83.0% 溃疡复发自由率（1 年，愈合后）

The median ulcer age in the study was 169 days, with a maximum ulcer age of 6,816 days (18 years and 8 months), demonstrating that VenaSeal can heal even the most chronic and long-standing ulcers​.

研究中溃疡的中位年龄为169天，最大溃疡年龄为6816天（18年零8个月），这表明VenaSeal甚至可以治愈最慢性、病程最长的溃疡。

Safety and effectiveness endpoints

安全性与有效性终点

Safety events underwent rigorous review by an independent committee to ensure objective and representative assessment. The following rates were observed:

安全性事件经过了独立委员会的严格审查，以确保评估的客观性和代表性。观察到以下发生率：

VenaSeal system-specific safety events were consistent with prospective literature. Events included: hypersensitivity to VenaSeal (0.8%), phlebitis (8.8%), granuloma (1.6%), Ablation-related thrombus extension (ARTE) (2.4%)

VenaSeal系统特定的安全事件与前瞻性文献一致。事件包括：对VenaSeal过敏（0.8%）、静脉炎（8.8%）、肉芽肿（1.6%）、消融相关血栓延伸（ARTE）（2.4%）。

No deaths related to device or procedure​

无与设备或程序相关的死亡事件​

Eight serious adverse events (SAEs) related to the device or procedure: infections (4)​, superficial vein thrombosis (3), granuloma (1)​

与设备或程序相关的八个严重不良事件（SAE）：感染 (4)、浅静脉血栓形成 (3)、肉芽肿 (1)。

Low hypersensitivity rate of 0.8%​

低超敏反应率0.8%​

“This new data from the Spectrum Program expands the body of knowledge showing that VenaSeal is an effective treatment across the full range of superficial venous disease severity,” said David Moeller, senior vice president and president, Peripheral Vascular Health, which is part of the Cardiovascular portfolio at Medtronic.

“Spectrum 项目的新数据扩充了现有的知识体系，表明 VenaSeal 在整个浅表静脉疾病严重程度范围内都是一种有效的治疗方法，”美敦力心血管业务组合中周围血管健康部门的高级副总裁兼总裁大卫·莫勒表示。

“It demonstrates that VenaSeal is appropriate and reliable for complex SVI cases, building on the breadth of published data on treatment earlier in the course of the disease.”.

“它证明了VenaSeal 对于复杂的 SVI 病例是适用且可靠的，基于疾病早期治疗的已发表数据的广度。”

The

The

VenaSeal Spectrum Program

静脉密封光谱计划

is one of the largest and most innovative clinical programs in the treatment of venous disease. More information is available at

是治疗静脉疾病最大和最具创新性的临床项目之一。更多信息可访问

medtronic.com/spectrum

medtronic.com/spectrum

. The VenaSeal closure system is commercially available in 70 countries, including the U.S. and all EU member countries.

VenaSeal闭合系统已在包括美国和所有欧盟成员国在内的70个国家上市销售。

Cai PL, Hitchman LH, Mohamed AH, Smith GE, Chetter I, Carradice D. Endovenous ablation for venous leg ulcers.

蔡PL，希奇曼LH，穆罕默德AH，史密斯GE，切特I，卡拉迪斯D。静脉曲张性腿部溃疡的腔内消融治疗。

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 more than 150 countries.

大胆思考。更有力的行动。我们是美敦力。美敦力公共有限公司，总部位于爱尔兰戈尔韦，是一家领先的全球医疗技术公司，通过寻找并发现解决方案，大胆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——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

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 .

期待我们带来更多的成果，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，以及为世界创造更好的结果。在我们所做的一切中，我们正在创造非凡的工程。如需更多关于美敦力的信息，请访问。