Amet withdrew the application for clinical trial approval of "Fully degradable peripheral vascular drug-eluting stent system", and will resubmit after further improvement of the application materials
Release time:
2020-06-15 09:17
Source:
Our company's patent application for the structural design of vascular stent, "A stent with an obturator structure, its preparation method and use", was officially authorized by the State Intellectual Property Office of China on June 30, 2020. Patent number ZL201580079706.4. Our company's 3D printed fully degradable coronary stent, AMSorb®, adopts this structural design and has entered the clinical trial stage. The U.S. patent application for this patent was granted an invention patent by the U.S. Patent Office in March 2020.
The structural design of vascular stent is one of the important factors affecting the clinical effect of vascular stent. The structural design of the stent directly affects the radial support force of the vascular stent, hemodynamics, and the delivery and adherence of the stent.
In September 2019, Amet submitted an application for clinical trial approval of the self-developed "Fully Degradable Peripheral Vascular Drug-Eluting Stent System" to the NMPA Device Review Center by online submission. At the end of December 2019, the NMPA information supplement request was received and the application supplementary materials were submitted online. Recently, Amet has fully communicated with the Center for Device Examination. After careful consideration, Amet decided to withdraw the application for clinical trial approval of the product, and resubmit the application as soon as possible before the end of the year after the information is further improved.
Amet's ongoing clinical trials of the "Fully Degradable Coronary Drug-Eluting Stent System" are not affected and are still ongoing.
The fully degradable coronary drug-eluting stent AMSorb and the fully degradable peripheral vascular drug-eluting stent PeriSorb developed by Amet using its own patented technology have won the 13th Five-Year Major Research and Development Project of the Ministry of Science and Technology, the Beijing Municipal Science and Technology Commission, Zhongguancun and Haidian District and other special funds support. Its core technology has been authorized by 3 Chinese invention patents and 2 American invention patents.
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