Varian announced its Embozene microspheres have received CE mark for genicular artery embolisation (GAE) to treat knee osteoarthritis.
The regulatory clearance makes Embozene the first embolic agent specifically approved in Europe for the minimally invasive procedure. GAE targets inflammation in the knee joint by blocking small blood vessels with microspheres delivered through a catheter. The approach is designed to alleviate pain for patients who are not yet ready for, or prefer to delay, total knee replacement surgery.
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Knee osteoarthritis affects nearly 375 million people worldwide, according to Varian. Current treatments such as physical therapy, medications and injections often provide only temporary relief.
Varian, a Siemens Healthineers company, said the CE Mark follows completion of enrollment in the GENESIS II trial. The randomized, sham-controlled study is evaluating the safety and efficacy of GAE in patients with knee osteoarthritis at Royal Berkshire Hospital in Reading, U.K., under principal investigator Prof. Mark Little.
“Achieving CE Mark alongside full enrollment in the GENESIS II trial marks a pivotal moment for minimally invasive knee care,” said David Hahn, chief medical officer of interventional solutions at 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 microspheres are already available in 60 countries for embolisation of hypervascular tumors, uterine fibroids, and benign prostatic hyperplasia. The FDA granted breakthrough device designation in 2021 for GAE in knee osteoarthritis.
