[I-AEPCJS-01] Japan team and RWD illuminate our patients’ less invasive future
Keywords:real world data, registry, new device
The development of cardiac and endovascular devices for pediatric and congenital heart disease has been delayed in Japan and the United States due to the rarity of the patient population, inadequate profitability of the industries, and hurdles in conducting clinical trials, despite the high medical needs with less invasiveness. In recent years, the industry-government-academia alliance between Japan and the United States has evolved. In the mean time, real world data (RWD) derived from the national registry has come to be utilized in regulatory affairs. This trend has brought minimally invasive treatment for low-birth-weight infants suffering from patent ductus arteriosus and adults with right heart failure due to pulmonary valve dysfunction late after surgical repair in Japan. We hope that the teamwork will establish a standardized review system for emerging medical devices and deliver them to our patients more promptly and appropriately.