Varian has received a breakthrough device designation from the U.S. Food and Drug Administration for its Embozene microspheres for genicular artery embolization (GAE) for symptomatic knee osteoarthritis.
Embozene microspheres received the designation because of their potential to offer a more effective treatment for appropriate patients with osteoarthritis of the knee, the company said.
GAE is an outpatient minimally invasive procedure performed by interventional radiologists intended to provide immediate and long-term pain relief for patients with osteoarthritis. The procedure blocks blood flow to the lining of the knee with microspheres delivered via a catheter to reduce inflammation.
Varian's microspheres have received FDA clearance for use in hypervascular tumors, arteriovenous malformations, uterine fibroids, and benign prostatic hyperplasia.
