The first International Summit on Cardiovascular Innovations Summit (ISCI) was opened at Shanghai yesterday. Over 600 participants were attracted to attend this highest level of event in cardiovascular field. This conference was sponsored by Center for Cardiovascular Innovations (CCI) and China Cardiovascular Association and co-sponsored by Xinfenghui (CCI Wechat official account), Firestone Inventing, etc. Ge Junbo, the chairman of the conference and academician of Chinese Academy of Sciences, said in an interview that the domestically developed completely biodegradable poly-lactic acid stent (Xinsorb) has finished large-scale clinical trials and progressed to special approval procedure for innovative medical devices, making a critical step for premarket approval (PMA).

Biodegradable stent is a global hot area of research in recent years, regarded as the fourth revolution in the history of percutaneous coronary intervention. It is reported that on Sept. 5, 2013, with the leadership of Ge Junbo academician, the cardiology team of Zhongshan Hospital completed the first implantation of domestically developed completely biodegradable poly-lactic acid stent (Xinsorb). As of now, a total of 1,230 subjected have been enrolled and 38 clinical centers have participated in this clinical trial. 

Meanwhile, the leaders of Center for Medical Device Evaluation (CMDE) under CFDA said in the conference that as our approval mode of medical devices is in the progress of reformation, innovative medical devices with significantly clinical values may be provided with priority in registration, technical evaluation and administrative evaluation.