SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

Who can take part

• Subject is able and willing to provide written informed consent, and
• Clinical diagnosis of knee OA, and
• Moderate to severe knee pain (WOMAC Pain ≥ 10), and
• Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
• Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
• Age ≥ 40 years and < 80 years, and
• Able to comply with all treatments and follow-up visits

Who cannot take part

• 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
• Prior knee replacement surgery in the target knee, or
• Prior iodinated contrast reaction resulting in anaphylaxis, or
• 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
• Current infection of target joint, or
• Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
• History of uncorrectable coagulopathy, or
• Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
• Severe knee OA (Kellgren-Lawrence grade 4), or
• Life expectancy less than 36 months, or
• Pain score of >3 NRS on the non-target knee, or
• An acute internal derangement of the target knee, or
• Contraindication to MRI, or
• At the discretion of the Principal Investigator