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.

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.