The randomized controlled trial of 3D printing fully degradable coronary drug-eluting stent system, an innovative device independently developed by Beijing Amet, successfully completed the enrollment of the first three subjects
Release time:
2021-07-13 09:11
Source:
Recently, a randomized controlled clinical trial of the innovative medical device "3D printing fully degradable coronary drug-eluting stent system (trade name: AMSorbTM)" independently developed by Beijing Amat Medical Devices Co., Ltd. was conducted in Beijing affiliated to Capital Medical University. Anzhen Hospital successfully completed the enrollment of the first three subjects (including two in the experimental group and one in the control group). All three subjects were in good postoperative condition and have been discharged from the hospital.
In the two experimental groups, one case was implanted with a 3.0 × 23mm Ammet AMSorbTM stent in the subject's right coronary artery lesion; the other case was implanted in the subject's left circumflex artery lesion with a size of 3.0 mm. One Amate AMSorbTM stent with a size of 23mm, the interventional treatment of target lesions was successful, and the results after stent implantation were satisfactory.
"Multi-center, prospective clinical registration trial of fully degradable coronary drug-eluting stent system (trade name: AMSorbTM)" by Professor Huo Yong of Peking University First Hospital as the principal investigator, and Professor Zhou Yujie of Beijing Anzhen Hospital as the joint researcher The principal investigator, the small sample first-in-man trial (FIM, First in Man) in the registration trial has successfully completed the enrollment of all 30 subjects on November 19, 2019, and the follow-up of the FIM trial is ongoing, based on The existing follow-up data fully confirmed the good safety of the Amater AMSorbTM stent.
The successful launch of the randomized controlled clinical trial of the 3D printed fully degradable coronary drug-eluting stent system (trade name: Amater AMSorbTM) marks a big step forward in the clinical registration trial process of Amater AMSorbTM, and also provides a solid foundation for the follow-up Amater AMSorbTM clinical registration trial. The registration forensics of AMSorbTM stents laid the foundation.
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