The First Human Implantation of a 3D Printed Degradable Stent Completed Successfully by An Enterprise in the ZGC Medical Device Park
The world’s first 3D printed fully degradable coronary drug-eluting stent system (AMSorbTM) is developed by Huo Yong, professor of The First Hospital of Peking University, and Zhou Yujie, deputy director of Beijing Anzhen Hospital. Its clinical trial has been approved by NMPA (National Medical Products Administration) on April, 2019 and by the Ethics Committee of The First Hospital of Peking University on July 3.
On July 23, Chen Ming, professor of the cardiology department of The First Hospital of Peking University, successfully complete the first operation of AMSorbTM stent implantation. According to Mr. Chen, the patient is a 49-year-old man, whose coronary angiographic result showed 95% stenosis in the middle segment of the left anterior descending ramus. It was urgent for him to have the stent implantation operation. After OCT measurement and full predilation of the lesion, Mr. Chen made decision to implant an AMSorbTM stent.
During operation, the stent reached the lesion site after going through several bends successfully, accurately positioned based on the mark points at both ends of the stent, fully post-dilatating with the help of a high-pressure balloon. The angiographic result and OCT images of the reexamination showed that the stent was well attached to the vascular wall. The whole operation went very smoothly and the results of implantation was satisfactory. The patient is in good postoperative condition and has been discharged.
The clinical trial was applied by Beijing Advanced Medical Technologies, Ltd. Inc., with the medical statistical center of the National Cardiovascular Disease Center as the statistical analysis agency and Beijing Jingrui Tianhe Medical Technology Development co., Ltd. as the CRO. The feasibility clinical tests are undertaken by 5 institutions: The First Hospital of Peking University, Beijing Anzhen Hospital affiliated to Capital Medical University, Zhongshan Hospital affiliated to Fudan University, Liaoning People’s Hospital and Tianjin Chest Hospital. Randomized controlled trials and single-arm trials will be conducted in 29 clinical trial facilities nationwide.
This is the world’s first implantation of 3D printed fully degraded coronary stent into a human body, marking that the 3D printed stent with completely independent IP rights has successfully entered the clinical trial stage, and also marking that China’s 3D printing technology has reached the world’s advanced level. This innovative product has been supported by the Ministry of Science and Technology and scientific research funds of Beijing, Zhongguancun and Haidian. It has begun to go through the “Special Approval Procedures for Innovative Medical Devices” specified by NMPA.
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