Varian’s Embozene Microspheres to Be Evaluated for Genicular Artery Embolization to Treat Knee Osteoarthritis

November 17, 2022—Varian, a Siemens Healthineers company, announced that the first patient was enrolled in the GENESIS II trial studying Embozene microspheres for genicular artery embolization (GAE) to treat mild to moderate knee osteoarthritis. The large randomized clinical trial is assessing pain relief from this condition.

GENESIS II is being conducted at the University Department of Radiology, Royal Berkshire NHS Foundation Trust, in Reading, United Kingdom. The study’s Principal Investigator is Professor Mark Little, MD, Consultant Diagnostic & Interventional Radiologist, Radiology Research Lead, at the University Department of Radiology at Royal Berkshire.

According to the company, in the GENESIS II trial, patients with knee osteoarthritis will either receive treatment with the Embozene microspheres or a sham control. Patients have the option to receive Embozene treatment later in the clinical trial. This trial design allows more accurate assessment of pain relief from the new treatment, noted the company.

“In GENESIS, our previous 38-patient prospective study, GAE in patients with mild to moderate knee osteoarthritis was found to be safe and effective at early follow-up,” commented Prof. Little in Varian's press release. “We're excited to build upon this foundation with GENESIS II, which has the potential to improve our understanding of the clinical applications for the procedure.”

Prof. Little further noted, “Including a sham-treated group provides the opportunity to validate the findings of GENESIS as well as gain insight into longer term follow-up and patient quality of life.”

The company stated that in the minimally invasive GAE procedure, the Embozene microspheres are delivered via catheter into the genicular arteries to the small blood vessels that supply the knee joint and contribute to the inflammatory process. The procedure is intended to reduce the blood supply to the areas of greatest inflammation in the knee with the goal of reducing pain.

In October 2021, the company announced that the FDA granted Breakthrough Device designation for Embozene microspheres for GAE for osteoarthritis.

Currently, the Embozene device is used to treat hypervascular tumors, arteriovenous malformations, uterine fibroids, and benign prostatic hyperplasia; it is marketed in 60 countries for embolization. Embolics are not yet authorized for marketing anywhere for genicular artery embolization, noted Varian.