First Patient Treated in GENESIS II Trial of Genicular Artery Embolization for Knee Osteoarthritis

Varian, a Siemens Healthineer company, announced the first trial participant has been treated as part of GENESIS II (Genicular artEry embolisatioN in patiEnts with oSteoarthrItiS of the knee), a study of Embozene microspheres for genicular artery embolization (GAE) as treatment of mild to moderate knee osteoarthritis.

GENESIS II is being conducted at the University Department of Radiology, Royal Berkshire NHS Foundation Trust, in Reading, UK. The trial targets mild to moderate osteoarthritis (OA) of the knee joint, a common condition and a leading cause of chronic disability. GAE is a minimally invasive procedure in which a small catheter is advanced into the genicular arteries, the small blood vessels that supply the knee joint and contribute to the inflammatory process. The Embozene microspheres are delivered through the catheter to reduce the blood supply to the areas of greatest inflammation in the knee with the goal of reducing pain.

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

In October 2021, the US Food and Drug Administration (FDA) granted Breakthrough Device Designation for Embozene microspheres for GAE for OA. The medical device is marketed in 60 countries for embolization, a procedure that blocks or reduces blood supply to a target area in the body. Currently, Embozene is used to treat hypervascular tumors, arteriovenous malformations, uterine fibroids, and benign prostatic hyperplasia. Embolics are not yet authorized for marketing anywhere for genicular artery embolization.

Professor Mark Little, Consultant Diagnostic & Interventional Radiologist, Radiology Research Lead, at the University Department of Radiology at the Royal Berkshire NHS Foundation Trust, is the Principal Investigator of the GENESIS II study. "In GENESIS, our previous 38-patient prospective study, GAE in patients with mild to moderate knee OA was found to be safe and effective at early follow-up," said Professor Little. "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. 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."

"Varian is committed to supporting research that has the potential to improve outcomes and enhance the quality of life for patients around the world, and we view the GENESIS II study as an important opportunity to do this," said David Hahn, MD, Chief Medical Officer, Interventional Solutions, at Varian. "Interventional radiology is defined by minimally invasive techniques, and we believe the treatment of chronic pain is a natural fit for this specialty, particularly given the World Health Organization's guidance on this subject. We look forward to better understanding the possible role of GAE in addressing a pressing challenge for care providers and patients."