What is Resorbable Embolization?

Genicular artery embolization (GAE), or embolization of the knee, is a minimally invasive procedure that provides immediate and long-term pain relief for patients with OA. GAE blocks the blood flow to the neo-vessels that are inflamed. By blocking these vessels, there is a reduction in the amount of inflammation and can help or eliminate knee pain from OA. GAE is for patients who have struggled with arthritis, severe knee pain and have been resistant to conservative therapy for at least 3 months. It is an alternative treatment for patients that are poor surgical candidates or do not want to undergo invasive surgery.

The Procedure

Symptomatic knee osteoarthritis (OA) affects more than 1 in 10 adults based on National Consensus data (NHANES III) and is a leading cause of disability [1,2]. The cause on knee OA is a multifactorial and pain can persist despite medical and surgical treatments [3,4]. In conjunction with cartilage breakdown, literature suggests that chronic bone and synovial inflammation stimulates angiogenesis, hyperplasia and ongoing recruitment of inflammatory cells that leads to sensory nerve growth, which contributes to pain [5-8].

Okuno et al. first described treatment of angiographically abnormal vasculature associated with areas of osteoarthritic knee pain by percutaneous embolization with a non-permanent agent, imipenem/cilastatin sodium (IPM/CS) or permanent embolic, embozene microspheres, based on experience from treating chronic musculoskeletal pain for tendinopathy and adhesive capsulitis.

In conclusion, current data suggests that GAE holds promise as a treatment for osteoarthritis related knee pain.

 

 

 

(An extract from Genicular Artery Embolization for Osteoarthritis Related Knee Pain: A Systematic Review and Qualitative Analysis of Clinical Outcomes Casadaban, Leigh C. Mandell, Jacob C. Epelboym, Yan.)

Results of our Human Trial

The first in human study of SakuraBead was carried out with 15 patients for genicular artery embolization (GAE) to treat pain secondary to Knee Osteoarthritis. The results for Pain VAS and WOMAC questionnaire scores demonstrate that treatment using SakuraBead provided a statistically significant improvement in pain, stiffness and physical function for patients. To date, no serious adverse events (SAEs) have been reported in this clinical investigation. The clinical investigation has demonstrated that SakuraBead resorbable microspheres are safe and statistically effective for use in arterial embolization and the results show the benefits of the device out-weigh the risks. The study shows that 14/15 (93%) of the patients showed a significant decrease in their knee pain by their 6 month follow-up, with a mean reduction of 74.75%. 14/15 patients also had a reduction in pain medication in comparison to before the procedure.

References:

  1. Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94.
    J Rheumatol. 2006;33(11):2271–9.
  2. Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pa. Arch Phys Med Rehabil. 2014;95(5):986–995.e1.
  3. Allen KD, Golightly YM. State of the evidence. Curr Opin Rheumatol. 2015;27(3):276–83
  4. . What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients | BMJ Open
  5. Osteoarthritis: an update with relevance for clinical practice – The Lancet
  6. The role of synovitis in pathophysiology and clinical symptoms of osteoarthritis | Nature Reviews Rheumatology
  7. Walsh DA, Mcwilliams DF, Turley MJ, Dixon MR, Franse`s RE, Mapp PI, et al. Angiogenesis and nerve growth factor at the osteochondral junction in rheumatoid arthritis and osteoarthritis.
    Rheumatology. 2010;49(10):1852–61.
  8. Increased vascular penetration and nerve growth in the meniscus: a potential source of pain in osteoarthritis | Annals of the Rheumatic Diseases (bmj.com)