Varian Receives CE Mark for Embozene Microspheres in Knee Osteoarthritis Treatment
Varian, a Siemens Healthineers company, has announced that its Embozene microspheres have received CE Mark approval for use in Genicular Artery Embolisation (GAE), a new treatment option for knee osteoarthritis. This marks the first time an embolic agent has been approved specifically for this procedure, which targets inflammation to relieve pain and improve mobility in patients with knee osteoarthritis.
Knee osteoarthritis affects an estimated 375 million people worldwide and is a leading cause of disability, often reducing mobility and quality of life. Current treatments, such as physical therapy, medications, and injections, offer temporary relief but do not address the underlying inflammation that causes pain. GAE, a minimally invasive procedure, involves delivering Embozene microspheres to the genicular arteries, which supply blood to the knee joint. By reducing blood flow to areas with the most inflammation, the procedure aims to alleviate pain and potentially delay the need for knee replacement surgery.
Varian’s Embozene microspheres have been successfully used for various embolisation treatments, including for tumors and uterine fibroids. The approval for GAE marks a significant expansion of the product’s application. The company has also completed patient enrollment in the GENESIS II trial, a randomized, sham-controlled study evaluating the safety and efficacy of GAE for knee osteoarthritis. The trial is being conducted at Royal Berkshire Hospital in the UK under the leadership of Prof. Mark Little.
Dr. David Hahn, Chief Medical Officer of Varian’s Interventional Solutions division, noted that achieving the CE Mark and completing enrollment in the GENESIS II trial are significant milestones in the development of GAE as a treatment for knee osteoarthritis. He highlighted that this new option offers hope for patients suffering from chronic knee pain, providing a non-surgical alternative with the potential to improve long-term mobility.
Embozene has been marketed in 60 countries for other embolisation treatments and has received Breakthrough Device Designation from the U.S. FDA for its use in knee osteoarthritis. With this new CE Mark, Varian continues to expand its portfolio of innovative, image-guided therapies aimed at improving patient outcomes and broadening treatment options for chronic musculoskeletal conditions.
