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Promote the deep integration of obstetrics and medicine, accelerate the clinical research of innovative products -- the city's intravascular interventional surgery robot successfully completed "multiple first cases"

Release time:

2022-07-20

Source:

BioShanghai

Recently, in the field of endovascular intervention, Shanghai Operate Robot Co., LTD., endovascular interventional surgery robot ALLVAS™ Major breakthroughs have been made in clinical research.

In August 2021, Professor Lu Qingsheng's team from the Department of Vascular Surgery of Changhai Hospital Affiliated to China Naval Medical University successfully completed the world's first robotic endovascular repair of thoracic aortic aneurysm and abdominal aortic aneurysm using ALLVASTM. In March 2022, Professor Zhang Bili's team from the Department of Cardiology of the hospital, Another case of universal robot-assisted whole-process coronary (PCI) surgery was successfully completed, which was also the first coronary intervention surgery assisted by universal surgical robot, and refreshed a new height in the development of domestic endovascular interventional surgery robot.

The clinical project was sponsored by Shanghai Operate Robot Co., LTD., and assisted by Beichao Medical Technology (Shanghai) Co., LTD. (CRO) to evaluate the safety and feasibility of the surgical robot. The project initially completed the first patient of vascular surgery in August last year, and then successfully completed the world's first robot-assisted endovascular interventional surgery such as aortic covered stent intervention and peripheral vascular stent intervention, which has gained wide attention from the society at home and abroad.

 

 

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Endovascular interventional surgery robot ALLVAS™

(Photo source: official account“The Shanghai Operation Robot surgical robot”)

 

It is understood that the traditional vascular interventional surgery, on the one hand, the operator will face radiation damage, need to wear heavy radiation protection clothing; On the other hand, traditional interventional surgery relies on the surgeon's experience and muscle memory to complete the operation, which is difficult to achieve accurate operation. By using vascular interventional surgery robot to perform surgery, the doctor is liberated from the operating room, there is no potential radiation risk, and its surgical trauma is small, and it can also make many high-risk patients who can not tolerate surgery to get a better chance of treatment.

Behind the success of revolutionary operation after operation is not only the efforts of Shanghai Changhai Hospital and clinical research team, but also the joint construction of Shanghai Economic and Information Technology Commission and Shenkang Center. Municipal Hospital Biomedical Clinical Trial Research and Application Platform (HI-CLIP) - Clinical Trial accelerator & RDQuo; The propelling and accelerating effect of. In the early stage of the clinical research project, the sponsor and CRO institutions submitted the accelerated application on the clinical trial accelerator platform and entered the online acceptance process. On the same day, Shanghai Economy and Information Technology Commission completed the preliminary review and formed an opinion agreeing with the recommendation. After multiple rounds of communication and promotion between Shenkang Center and relevant GCP institutions, the clinical expert team of Shanghai Changhai Hospital, the national drug clinical trial institution, the ethics committee and other relevant departments quickly launched, timely feedback, interlinked, so that the project quickly entered the offline implementation process.

 

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Shanghai Operation Robot and Beichao Medical Technology related programs, said. Clinical scientific research and achievements transformation, must be based on a high level of hospital, it will provide the feasibility of the transformation of technical achievements, project efficiency, standardization and lay a solid foundation, and the clinical trial accelerator is we in the experimental scheme and clinical institutions, communication with the ethics committee in such aspects as ethical review feedback. It is with the support of many parties that this project can be quickly and efficiently promoted, and successfully applied to clinical & RDquo. . It was revealed that ALLVAS&trade, Shanghai Operation Robot Medical's intravascular interventional surgery robot; It is expected to obtain the registration certificate in 2023 and officially start serving patients.

“Municipal Hospital Biomedical Clinical Trial Research and Application Platform (HI-CLIP) - Clinical Trial accelerator & RDQuo; In December 2020, it was jointly established by Shanghai Economy and Information Technology Commission, Science and Technology Foundation, and Shenkang Hospital Development Center. By establishing a normal work docking mechanism, it built a bridge between the industry leading department and the municipal hospital management department, and formed an enterprise & MDASH. Industry leading department & MDASH; Municipal hospital administration & MDASH; The chain connection of hospitals can effectively reduce communication costs, connect the needs and resources of enterprises and hospitals, and improve the quality and efficiency of industry-medical integration. Especially for the key projects of municipal industrial development, recommended by the industry leading department, they can be preferentially entered into clinical trials in municipal and municipal hospitals, and accelerated in all links. Through this accelerator, the traditional series way of seeking each hospital offline has been changed, and a parallel way of receiving information online by each hospital at the same time after overall management has been formed. It is expected to shorten the average start-up time of clinical trials from 6-13 months to 3-5 months.

 

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ALLVAS™,A major breakthrough,Endovascular intervention