Varian, a division of Siemens Healthineers, has secured CE mark for its Embozene microspheres for genicular artery embolisation (GAE) to treat knee osteoarthritis.
GAE is a minimally invasive procedure intended to alleviate pain by targeting inflammation in patients suffering from knee osteoarthritis.
Embozene is already offered in 60 countries for the embolisation of hypervascular tumours, uterine fibroids, and benign prostatic hyperplasia.
In 2021, the US Food and Drug Administration (FDA) granted breakthrough device designation for Embozene, allowing GAE to treat knee osteoarthritis.
With the current CE mark approval, Embozene becomes the first and only embolic agent approved for GAE in Europe.
Varian interventional solutions chief medical officer David Hahn said: “Achieving CE Mark alongside full enrollment in the GENESIS II trial marks a pivotal moment for minimally invasive knee care.
“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.”
Unlike traditional treatments, GAE represents a potential solution for pain management in knee osteoarthritis patients who are not ready for knee replacement surgery.
The procedure involves inserting a small catheter into the genicular arteries, which are responsible for supplying the knee joint and contributing to inflammation.
Embozene microspheres are then administered to diminish blood flow in the most inflamed areas, aiming to relieve pain.
GAE using Embozene microspheres seeks to offer pain management alternatives for patients who’ve exhausted other treatments and wish to delay joint replacement.
Furthermore, Varian has completed patient recruitment in the GENESIS II clinical trial.
The randomised, sham-controlled study, led by Mark Little from the UK’s Royal Berkshire Hospital, will evaluate the safety and effectiveness of GAE in treating knee osteoarthritis.
