Varian, a Siemens Healthineers company, announced today that its Embozene microspheres have received CE Marking for Genicular Artery Embolisation (GAE) for knee osteoarthritis. This regulatory milestone makes Embozene the first—and only—embolic agent to be CE Marked specifically for GAE, a minimally invasive procedure intended to target inflammation and help relieve pain in patients with knee osteoarthritis..

瓦里安，西门子医疗旗下公司，今日宣布其Embozene微球已获得用于膝骨关节炎的膝关节动脉栓塞术（GAE）的CE认证。这一监管里程碑使Embozene成为首个且唯一一个专门针对GAE获得CE认证的栓塞剂，GAE是一种微创手术，旨在靶向炎症并帮助缓解膝骨关节炎患者的疼痛。

Knee osteoarthritis is widespread, with a reported prevalence of nearly 375 million cases globally¹ and can significantly impair physical function and quality of life. While current treatments – such as physical therapy, medications, and intra-articular injections – offer temporary relief, many patients are not yet ready for, or wish to delay, total knee replacement surgery.

膝骨关节炎普遍存在，据报道全球病例接近3.75亿¹，且会显著影响身体功能和生活质量。尽管当前的治疗方法（如物理治疗、药物和关节内注射）能够提供暂时缓解，但许多患者尚未准备好接受，或希望推迟全膝关节置换手术。

This gap in care highlights the need for new options that can help patients manage pain and maintain function..

这种护理上的差距凸显了需要新的选择来帮助患者管理疼痛和维持功能。

GAE is designed to help fill that gap. The procedure involves advancing a small catheter into the genicular arteries—tiny vessels that supply the knee joint and contribute to inflammation—and delivering Embozene microspheres to reduce blood flow to areas of greatest inflammation, with the goal of pain relief..

GAE 旨在帮助填补这一空白。该手术涉及将一根小导管推进到膝关节动脉——供应膝关节并导致炎症的微小血管——并输送 Embozene 微球以减少最严重炎症区域的血流，从而达到缓解疼痛的目的。

By enabling Genicular Artery Embolisation with Embozene microspheres, Varian aims to support patients who have exhausted other measures and seek alternatives to joint replacement surgery. This milestone underscores Varian’s continued investment and commitment to advancing innovative, image-guided therapies that improve patient outcomes and expand treatment options for chronic musculoskeletal conditions..

通过使用Embozene微球实现膝关节动脉栓塞，瓦里安旨在帮助那些已尝试其他方法无效并寻求关节置换手术替代方案的患者。这一里程碑凸显了瓦里安持续投资并致力于推进创新的图像引导疗法，以改善患者的治疗效果，并为慢性肌肉骨骼疾病扩展治疗选择。

In parallel, the Varian-sponsored GENESIS II trial for GAE has successfully completed patient enrollment. This randomized, sham-controlled study led by principal investigator Prof. Mark Little at Royal Berkshire Hospital in Reading, United Kingdom, will evaluate the safety and efficacy of GAE for knee osteoarthritis..

与此同时，由瓦里安赞助的GAE相关的GENESIS II试验已成功完成患者入组。这项随机、假手术对照研究由英国雷丁皇家伯克郡医院的马克·利特尔教授主导，将评估GAE治疗膝骨关节炎的安全性和有效性。

“Achieving CE Mark alongside full enrollment in the GENESIS II trial marks a pivotal moment for minimally invasive knee care,” said David Hahn, MD, Chief Medical Officer, Interventional Solutions, Varian. “These milestones further validate Embozene’s precision-calibrated microspheres and demonstrate our commitment to advancing GAE as a therapeutic option.

“在GENESIS II试验全面入组的同时获得CE标志，这标志着微创膝关节护理的一个关键时刻，”瓦里安介入解决方案首席医疗官大卫·哈恩医学博士说道。“这些里程碑进一步验证了Embozene精确校准的微球，并展示了我们推进GAE作为治疗选择的承诺。”

For patients living with the daily burden of knee osteoarthritis, this development offers hope for meaningful pain relief and improved mobility.”.

对于每天承受膝关节骨性关节炎负担的患者来说，这一进展为他们带来了有意义的疼痛缓解和活动能力改善的希望。"

Embozene is already marketed in 60 countries for embolisation of hypervascular tumors, uterine fibroids, and benign prostatic hyperplasia. In 2021, the U.S. Food and Drug Administration granted Breakthrough Device Designation for GAE in knee osteoarthritis.

Embozene已在60个国家上市，用于高血管性肿瘤、子宫肌瘤和良性前列腺增生的栓塞治疗。2021年，美国食品药品监督管理局授予其在膝关节骨性关节炎的GAE疗法突破性设备称号。

© 2025 VARIAN MEDICAL SYSTEMS, INC. All trademarks are the property of their respective owners.

© 2025 瓦里安医疗系统公司，保留所有权利。所有商标均为其各自所有者的财产。

About Varian Interventional Solutions

瓦里安介入解决方案简介

Varian, a Siemens Healthineers company, is investing in the future of interventional radiology through our Interventional Solutions group. By partnering with interventional radiologists and researchers in the field, we are delivering a portfolio of intelligent solutions to benefit patients around the globe.

瓦里安（Varian），作为西门子医疗集团的一员，正通过我们的介入解决方案团队投资于介入放射学的未来。通过与该领域的介入放射学家和研究人员合作，我们正在提供一系列智能解决方案，以造福全球患者。

We are committed to enhancing the patient’s experience at every stage of care by developing and delivering innovative solutions in ablation, embolization and beyond..

我们致力于通过开发和提供消融、栓塞等领域的创新解决方案，提升患者在每个护理阶段的体验。

About Varian

关于瓦里安

At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship.

在瓦里安，一家西门子医疗公司，我们设想一个没有癌症恐惧的世界。75 多年来，瓦里安开发、制造和交付创新的技术和解决方案，帮助全球的医疗服务提供者每年治疗数百万患者。如今，作为西门子医疗的一员，我们支持癌症护理旅程的每一步——从筛查到幸存。

From advanced imaging and radiation therapy to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight.

从先进的影像和放射治疗，到全面的软件和服务，再到介入放射学，我们正在利用我们的视角力量，同时也在进行临床研究，以创建一个更高效、更个性化的护理路径。因为，对于世界各地的癌症患者来说，他们的战斗就是我们的战斗。

For more information, visit http://www.varian.com..

有关更多信息，请访问 http://www.varian.com。

¹Reference: Chen J, Chen X, Wang T, Li M, Dai H, Shang S, Cheng L, Tang Z, Liu S, Huang C. Global burden of knee osteoarthritis from 1990 to 2021: Trends, inequalities, and projections to 2035. PLoS One. 2025 Jun 11;20(6):e0320115. doi: 10.1371/journal.pone.0320115. PMID: 40498727; PMCID: PMC12157667..

¹参考文献：陈J，陈X，王T，李M，戴H，尚S，程L，唐Z，刘S，黄C。1990年至2021年全球膝关节骨关节炎负担：趋势、不平等及2035年预测。《公共科学图书馆·综合》。2025年6月11日；20（6）：e0320115。doi: 10.1371/journal.pone.0320115。PMID: 40498727；PMCID: PMC12157667。

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Contacts

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Press Contact

媒体联系人

Kristin Corey

克莉丝汀·科里

Varian Corporate Communications

瓦里安企业传播

[email protected]

[email protected]

Source: businesswire.com

来源：businesswire.com