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US FDA grants breakthrough device designation to Varian’s Embozene microspheres for GAE for symptomatic knee osteoarthritis

Palo Alto, California
Saturday, October 16, 2021, 13:00 Hrs  [IST]

Varian, a Siemens Healthineers company, announced that the US Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its Embozene microspheres for genicular artery embolization (GAE) for symptomatic knee osteoarthritis. 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 osteoarthritis of the knee. GAE is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process.

"GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration," said Siddharth Padia, M.D, director, interventional radiology at UCLA Santa Monica and the David Geffen School of Medicine at UCLA. "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." Dr. Padia is currently working to initiate a randomized clinical trial and a 400-patient registry.

Osteoarthritis is the most common form of arthritis and is a "wear and tear" degenerative joint disease that affects the cartilage and surrounding tissues. The knee is the joint that is most commonly affected with osteoarthritis and knee osteoarthritis is the leading cause of disability in the US adult population. It is estimated that 14 million individuals in the United States have symptomatic knee osteoarthritis, with half suffering from advanced knee osteoarthritis. The management of osteoarthritis of the knee is estimated to cost the United States healthcare system from $5.7 to $15 billion annually. Treatment for osteoarthritis often escalates from over-the-counter medications and physical therapy to cortisone injections and sometimes knee replacement surgery.

"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," said Frank Facchini, MD, FSIR, president, Varian Interventional Solutions. "Varian's investigational programme for GAE exemplifies our commitment to investing in our core technologies to determine their potential to treat the world's most debilitating diseases."

The FDA Breakthrough Device Programme 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.

Varian and Siemens Healthineers are investing in the future of interventional radiology. By partnering with interventional radiologists and researchers in the field, we are delivering a portfolio of intelligent solutions to benefit patients around the globe. We're committed to enhancing the patient experience at every stage of care by developing and delivering innovative solutions in ablation, embolization and beyond.


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