Summary

On Feb. 20, Osaka University Hospital received approval under a unique law to provide experimental therapy that is not covered by National Health Insurance (NHI)* to a patient with severe kidney failure. This is only the second time permission has been granted under the law, which came into enforcement April of last year. The intent of the law is to provide patients suffering from intractable diseases quick access to experimental therapies. Patients with severe kidney disease are not eligible for heart transplant or destination therapy. Prof. Yoshiki Sawa, Director of Cardiovascular Surgery, is testing an artificial heart system that includes attaching a cable to the back of the ear. This approach is expected to reduce the risk of infection compared with current artificial heart systems and improve the patient’s quality of life.

Background Picture: The cable system from a patient’s ear

 Currently, patients with severe kidney disease are not eligible for heart transplants or destination therapy.The auricle cable system proposed in this project complements artificial hearts and has received approval in foreign countries but not in Japan. This clinical research is expected to provide data for domestic approval.

Significance of the therapy

Attaching the cable wire to the back of the ear of patients with artificial hearts is expected to lower the risk of infection and increase quality of life. * In general, the patient is expected to cover the full cost of therapies that are not covered by the NHI. However, the new law permits government subsidies for experimental therapies that satisfy certain criteria.