Beijing, China - On September 15, 2023, the SkyWalker™ Orthopedic Joint Replacement Surgery Navigation System (the “SkyWalker™ Hip and Knee Joint Replacement Robot”), developed by MicroPort NaviBot(Suzhou) Co., Ltd (the “MicroPort® NaviBot®”) under Shanghai MicroPort MedBot (Group) Co., Ltd., received official approval for marketing from National Medical Products Administration (NMPA), and became the first approved domestic hip and knee integration orthopedic surgical robot containing self-developed robotic arms. It is compatible with Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA), and it is a whole new iteration and upgrade of product functions and surgical indications for the SkyWalker™ Orthopedic Surgical Robot. The approval of the SkyWalker™ Hip and Knee Joint Replacement Robot marks another milestone of MicroPort® MedBot® in the field of joint surgical treatment. It will further break apart foreign technological monopoly, allowing more joint operations and patients to benefit from domestic robot intelligent assistance system, and helping the domestic joint surgery enter the era of being more minimally invasive, more intelligent, and more accurate.
MicroPort® NaviBot® under MicroPort® MedBot® is one of the first professional teams in China to engage in breaking through the technologies of orthopedic joint surgical robot. In January of 2022, the R&D project of hip joint surgical robot system was officially initiated in Shanghai. This project was led by Huiwu Li, Chief Physician of Orthopedic Department of the Ninth People’s Hospital of Shanghai Jiaotong University School of Medicine and run by relying on the 2017 National Key Research and Development Program of “Minimally Invasive Joint Replacement Surgical Robot System R&D for Hip and Knee Compatibility, Safety and Efficiency”. Under the close collaboration of medical and engineering experts, and the rigorous scientific research and clinical validation surgery, the technical reliability and safety of the robot were sufficiently verified. This is the third surgical robot product of MicroPort® NaviBot® receiving marketing approval from NMPA, after the SkyWalker™ Orthopedic Surgical Robot and the Knee Arthroplasty Planning Software.
SkyWalker™ Hip and Knee Joint Replacement Robot is intended to assist the Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). It features platform design, standardization, precision, and personalization. Its pre-operative planning system will establish 3D models for the knee and the hip based on the patient’s preoperative CT scan data and generate personalized prosthesis implantation plan according to the physiology and anatomy of the patient; During surgery, it uses the self-developed highly agile and light-weight robotic arms for accurate osteotomy and grinding under human-machine cooperation; After surgery, the correction of limb alignment is significantly superior to traditional surgery, improving surgical accuracy and efficiency.
As the only available hip-knee compatible domestic orthopedic surgical robot containing self-developed robotic arms, it can achieve accurate positioning during operation, perform precise knee osteotomy and acetabular grinding, and accurately restore the limb alignment for the patient. The osteotomy, bone grinding, and prosthesis placement are more accurate and more efficient than traditional hip and knee arthroplasties. Its smart assistance system may prevent injuries caused by the intramedullary positioning of traditional surgery, lower the risk of dislodgement or surgery failure resulting from misplacement of the implanted acetabular cup, and reduce surgical complications, thus helping patient with quicker recover after surgery. As the devices for hip grinding, cup placement and knee osteotomy are comparable to that used in the traditional surgery, the robot system may greatly shorten the learning curve of the physicians and facilitate quick and proficient use.
This approval signifies that the SkyWalker™ Hip and Knee Joint Replacement Robot has achieved the complete and compatible applications of THA and TKA, providing strong technical support for Chinese joint surgeons to perform high-quality total hip arthroplasty. In the future, MicroPort® MedBot® will take full advantages of the outstanding performance of the SkyWalker™ Hip and Knee Joint Replacement Robot to drive the popularization of quality medical resources, accelerating the standardization of the clinical application of the orthopedic robot; stick to the road of medical and engineering cooperation, and combine global layout with the registration licenses from 5 continents, to provide diversified and more accurate total orthopedic robot-assisted surgery solutions to the patients worldwide.
Mr. Yu Liu, Executive Vice President and Chief Commercial Officer of the MicroPort® MedBot®, stated that, the approval of the SkyWalker™ Hip and Knee Joint Replacement Robot marks an important milestone in the marketization journey of SkyWalker™. It signifies the SkyWalker™ officially open up a new era of hip and knee integrated application. The successful registration helps drive the domestic joint surgical robot to a new height, further expand the robot’s operation application and scenarios, accelerate the domestic substitution of high-end medical devices, benefit patients across China, and reemphasize our initial intention of “Make Surgery Easier, Safer and Less Invasive.”
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2024-01-18Gansu Provincial People's Hospital has completed over 100 SkyWalker™-assisted total knee arthroplasty surgeries