Varian, a Siemens Healthineers company, today announced that the US Food and Drug Administration (FDA) has granted the company breakthrough device designation for its Embozene microspheres for genicular artery embolisation (GAE) for symptomatic knee osteoarthritis.
Embozene is a medical device that is FDA cleared for the embolisation of hypervascular tumours, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia.
According to Varian, Embozene microspheres received the designation due to their potential to offer a more effective treatment for appropriate patients with osteoarthritis of the knee. GAE is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process.
Siddharth Padia, director of interventional radiology at UCLA Santa Monica and the David Geffen School of Medicine at UCLA, Santa Monica, USA, said: “GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration.
“In a 40-patient, prospective study, the procedure resulted in a marked improvement in pain and function, and adverse events were uncommon and mild. I remain excited about the possibilities of this technology and its benefit to patients.” Padia is currently working to initiate a randomised clinical trial and a 400-patient registry.
The FDA breakthrough device program is intended to provide patients with more timely access to medical devices that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. As part of the program, the FDA expedites the traditional review and assessment process to help accelerate the development, assessment and review of the device for possible approval.
Frank Facchini, president of Varian Interventional Solutions, added: “GAE holds great promise in providing clinicians with a new, non-invasive treatment option, which may not only ameliorate pain, but reduce the economic burden of this common disease. Varian’s investigational program for GAE exemplifies our commitment to investing in our core technologies to determine their potential to treat the world’s most debilitating diseases.”