PALO ALTO, Calif.–(BUSINESS WIRE)–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.
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. This gap in care highlights the need for new options that can help patients manage pain and maintain function.
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.
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.
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.
“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. For patients living with the daily burden of knee osteoarthritis, this development offers hope for meaningful pain relief and improved mobility.”
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.
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About Varian Interventional Solutions
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. 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.
About Varian
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. 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. For more information, visit 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.
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