Varian’s Embozene Microspheres Receive FDA Breakthrough Device Designation to Treat Symptomatic Knee Osteoarthritis

October 13, 2021—Varian, a Siemens Healthineers company, announced that the FDA has granted Breakthrough Device designation for the company’s Embozene microspheres for genicular artery embolization (GAE) to treat symptomatic knee osteoarthritis. The Embozene device is currently cleared by the FDA for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids, and benign prostatic hyperplasia.

According to Varian, Embozene microspheres received the designation because of 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, MD, is currently working to initiate a randomized clinical trial and a 400-patient registry. Dr. Padia is Director, Interventional Radiology at UCLA Santa Monica and the David Geffen School of Medicine at UCLA in Los Angeles, California.

“GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration,” commented Siddharth Padia, MD, in the company’s press release. “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.”

The company noted that 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.

In April 2021, Siemens Healthineers AG announced the completion of its acquisition of Varian.