Varian, a Siemens Healthineers company, announced today that the first trial participant has been treated as part of GENESIS II, a study of Embozene microspheres for genicular artery embolization (GAE) as treatment of mild-to-moderate knee osteoarthritis. GENESIS II is the largest randomised clinical trial of GAE to assess pain relief from this condition.
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 involves a small catheter being advanced into the genicular arteries and 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 OA 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. Currently, Embozene is used to treat hypervascular tumours, arteriovenous malformations, uterine fibroids, and benign prostatic hyperplasia. Embolics are not yet authorised for marketing anywhere for GAE.
Mark Little, consultant diagnostic and interventional radiologist 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,” Little noted. “We are 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 to 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, 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 Organisation’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.”
