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R-ONE® Has Been Approved by The NMPA for Market Launch.
2022-12-13 GMT+8 PM 06:09

Shanghai, China - December 8th: Shanghai MicroPort MedBot (Group) Co., Ltd. (referred to as " MicroPort® MedBot® ") and Robocath S.A.S, a French company, jointly established a joint venture known as CathBot (Shanghai) Robotics Co., Ltd. (referred to as " CathBot®"). Their R-ONE® vascular intervention surgical robot (referred to as "R-ONE®") has officially obtained market approval from the National Medical Products Administration (NMPA). This is the first commercially available coronary vascular intervention surgical robot in China to complete multicenter clinical trials and obtain approval, filling the gap in the field of PCI surgical robots in our country and ushering in a new era of more precise and intelligent surgical robot-assisted coronary intervention treatment!

 

 

The approval of R-ONE® will accelerate the development of MicroPort® MedBot® in the field of vascular interventions. Together with Toumai® surgical robot in the field of endoscopy, SkyWalkerTM Orthopedic Robotics in the field of orthopedics, and Mona Lisa puncture robot in the field of percutaneous puncture, they will jointly establish MicroPort® MedBot® as a leader in the domestic surgical robot industry, continuously promoting the commercialization and scale development of the Chinese surgical robot industry.

 

 01

 

Multiple Core Technologies

 

Enhancing Clinical Value

 

R-ONE® is the first robot system in Europe to obtain CE certification in the field of interventional cardiology. Based on master-slave control technology, it aims to assist cardiovascular intervention physicians in performing more precise operations by providing precise techniques for assisting existing percutaneous coronary intervention (PCI) procedures, such as stent implantation (vascular angioplasty).

 

As a commercially available robot product strategically arranged by MicroPort® and MedBot®, R-ONE® possesses multiple core technologies. Its globally unique dual-hand biomimetic twisting technology can replicate human hand movements. It allows for 0-360° continuous rotation and translation, making it easier to navigate through tortuous vessels and complex lesions. With sub-millimeter-level stepping, it improves the accuracy of instrument deployment. The one-click lock/unlock feature enables single-person instrument exchange, improving surgical efficiency. The single-membrane full-coverage sterile consumables are quick to install and remove, avoiding cross-contamination and shortening surgical preparation time. The standardized surgical operation process has a short learning curve and is easy to use. The ergonomic radiation control console provides better protection for operators.

 

02

 

China-France Cooperation Model

 

Close Cooperation Yields Fruitful Results

 

The collaboration between MicroPort® MedBot® and Robocath S.A.S is considered a new model of China-France medical technology cooperation. The two parties jointly established the joint venture CathBot® in China and initiated the largest-scale multicenter registered clinical study of vascular intervention robots in China.

 

During the clinical trials, R-ONE® successfully completed various challenging and complex cases, including bifurcation lesions, highly angulated and tortuous vessel lesions, diffuse long lesions, calcified lesions, ostial lesions, and subtotal occlusions, and it has performed triple procedures multiple times. All surgeries achieved a 100% success rate and a 100% technical success rate, fully validating the safety, stability, and reliability of R-ONE®.

 

CathBot® is also committed to achieving local production and assembly of the R-ONE® system and participating in the development of other robotic systems for vascular interventions, as well as the development of remote intervention surgery and artificial intelligence-related technologies.

 

In July 2023, Professor Yundai Chen from the 301 Hospital remotely operated the "R-ONE®" robot over a distance of 2,800 kilometers, jointly performing the first-ever robot-assisted 5G ultra-long-distance percutaneous coronary intervention (PCI) surgery with Professor Yining Yang and his team from the Xinjiang Uygur Autonomous Region People's Hospital. The surgery was a complete success, showcasing the fruitful results of close cooperation between China and France.

 

03

 

Strong Collaboration for Coordinated Development

 

Creating a Comprehensive Coronary Intervention Solution

 

As a leader in the field of coronary intervention therapy, MicroPort® has been dedicated to safeguarding the well-being of every coronary heart disease patient. With over 20 years of industry experience, it has completed the comprehensive layout of an integrated solution for coronary heart disease in 2023. The solution covers key areas such as access routes, diagnosis and treatment, and surgical optimization, forming a global research and development, production, marketing, and service system. Since its market launch, the products have been sold in over 50 countries worldwide, covering markets in the Asia-Pacific region, Europe, South America, and more, maintaining a high market share and experiencing continuous growth.

 

The R-ONE® architecture is open and compatible with mainstream interventional instruments and catheter labs on the market, and its approval for market release will promote the further popularization of coronary intervention surgery, driving the development of consumables such as stents and balloons. Leveraging MicroPort® platform, through strong collaboration, R-ONE® will contribute to the future intelligent catheter lab solution for coronary intervention, making surgeries more digitalized, precise, and intelligent through interconnectivity between devices.

 

In addition, precise instrument delivery through R-ONE® can reduce intraoperative losses and improve the utilization of consumables, providing strong assistance to clinical doctors and ensuring high-quality and cost-effective interventional treatments.

 

Mr. Yu Liu, Executive Vice President and Chief Commercial Officer of the MicroPort® MedBot®, stated:

Globally, only a few vascular intervention surgical robots have been approved, mainly concentrated in the United States or Europe. With the official approval of R-ONE® by the National Medical Products Administration, this situation will change. Currently, as the world's first and only surgical robot company that has strategically positioned itself in the "six major golden specialties," MicroPort® MedBot® has obtained market approval and entered commercial development in the fields of laparoscopy, orthopedics, percutaneous puncture, and pan-vascular. It not only brings more precise and advanced intelligent surgical "assistants" to doctors in various departments, enhancing their clinical experience and extending their professional lifespan but also enables patients to receive more precise, safer, and more effective treatments. At the same time, with the popularization and promotion of surgical robot technology and 5G remote surgery, the challenges of specialized doctor training difficulty and high training costs will also be alleviated, contributing to the elimination of regional disparities in medical technology levels, benefiting patients, and achieving the goal of "Make surgery easier, safer and less invasive."

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