R-One (robot surgeon)

History

2022: Device conducts coronary angioplasty with 0% complications

Published on May 18, 2022, a European study of 62 patients showed that coronary angioplasty using an R-One robot surgeon manufactured by Robocath is safe and effective, and reduces doctors' exposure to radiation.

The R-Evolution trial was a prospective non-randomized clinical trial with one group designed to assess the safety and efficacy of the R-One robot when used for coronary angioplasty. The study included 62 patients (64 treated lesions) in six European centers. A quarter of lesions were classified as complex, noted Robocath.

Robot surgeon performs coronary angioplasty with 0% complications

Robocath, located in Rouen, reported 100% clinical success (no robot-related complications up to 30 days after the procedure); more than 95% of the success of technical operations; and 84.5% reduction in radiation load on the doctor. The company is expected to present detailed results on May 23, 2022 at the EuroPCR exhibition in Paris.

The R-One robot is specially designed for coronary angioplasty (stent implantation). From a radiation-protected control station, the doctor remotely controls the devices necessary for the procedure, such as guide wires, cylinders and stents, using joysticks. The R-One system was marked CE in 2019 and is used in Europe, Africa and China.

In addition to reducing radiation exposure, doctors using the R-One robot do not need to wear heavy lead protective equipment during the procedure. According to Robocath, the navigation and accuracy of the installation of cylinders and stents is improved due to the millimeter accuracy of the robot control and the fact that the devices are reliably fixed in the desired position when moving along the vascular channel.

{{quote 'In my experience, the average duration of the robotic procedure (19.9 ± 9.6 minutes) is approximately the same as with a manual procedure. Based on these results, the use of the robot really portends a new era in the treatment of heart disease, which we have been in dire need for 30 years, given the significant difficulties associated with this discipline, in particular the effects of X-rays, said interventional cardiologist and one of the main investigators of the trial, Eric Duran. }} One of the goals of the study was to measure the X-ray exposure of robotic operators compared to traditional manual operators. This was modeled by placing a pole next to the operations table. The average radiation dose received by the robot operator was 0.2 μSv, which is 300 times lower than the radiation received by the operator with simulation of manual control on the head and other parts of the body not protected by lead equipment. On average, performing coronary angioplasty by a robotic method reduces the effect of X-rays on the doctor by 84.5%. Robot operators still receive some X-ray exposure when manually installing the first device before starting the robotic part of the procedure; if the doctor has an assistant who installs the first device, the doctor's radiation dose is reduced by 100%.^[1]

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