Varian announced today that it received FDA breakthrough device designation for its Embozene microspheres for treating knee osteoarthritis.
Palo Alto, California-based Varian, a Siemens Healthineers (ETR:SHL) company, designed Embozene for genicular artery embolization (GAE) in treating symptomatic knee osteoarthritis. Embozene already holds FDA clearance for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia.
GAE as a treatment is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process, according to a news release.
UCLA Santa Monica and the David Geffen School of Medicine at UCLA director of interventional radiology Dr. Siddharth Padia said in the release that GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration.
According to Padia, a 40-patient study demonstrated a marked improvement in pain and function, with adverse events remaining uncommon and mild. Padia is currently working to initiate a randomized clinical trial and a 400-patient registry.
“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 president of interventional solutions Dr. Frank Facchini said in the release. “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.”