January 2022

VARIAN RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION FOR KNEE OA TREATMENT

Varian, a Siemens Healthineers company, announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its Embozene® microspheres for genicular artery embolization (GAE), a minimally invasive procedure, for symptomatic knee osteoarthritis (OA). Embozene is a medical device that is FDA cleared for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids, and benign prostatic hyperplasia.

Embozene microspheres received this designation due to their potential to offer a more effective treatment for appropriate patients with knee OA. GAE is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process.

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