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# Embozene ‘Breakthrough’ for Knee Osteoarthritis
- URL: https://www.fdaweb.com/embozene-breakthrough-for-knee-osteoarthritis/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150362

FDA has granted Varian a breakthrough device designation for its Embozene microspheres for genicular artery embolization (GAE) in treating symptomatic knee osteoarthritis. Embozene is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process, the company says. It is currently FDA cleared for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia.

The designation was based on data from a 40-patient, prospective study that demonstrated the procedure resulted in an improvement in pain and function, and adverse events were uncommon and mild, Varian says. A 400-patient randomized clinical trial and patient registry are now being planned, it adds.