SakuraBead Used As Resorbable Embolic for Genicular Artery Embolization

Eligibility Criteria

• 1. Subject is able and willing to provide written informed consent, and
• 2. Clinical diagnosis of knee OA, and
• 3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and
• 4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
• 5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
• 6. Age ≥ 40 years and \< 80 years, and
• 7. Able to comply with all treatments and follow-up visits.
• 1. Severe knee OA (Kellgren-Lawrence grade 4), or
• 2. Current infection of target joint, or
• 3. Life expectancy less than 36 months, or
• 4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
• 5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
• 6. Prior knee replacement surgery in the target knee, or
• 7. Pain score of \>3 NRS on the non-target knee, or
• 8. An acute internal derangement of the target knee, or
• 9. History of uncorrectable coagulopathy, or
• 10. Prior iodinated contrast reaction resulting in anaphylaxis, or
• 11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
• 12. Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
• 13. Contraindication to MRI, or
• 14. At the discretion of the Principal Investigator