A European examine of 62 sufferers confirmed that coronary angioplasties utilizing the R-One robotic from Robocath are protected and efficient, and cut back physicians’ publicity to radiation.
The R-Evolution trial was a potential, non-randomized, single-arm medical examine designed to evaluate the protection and efficacy of the R-One robotic when used for coronary angioplasties. A complete of 62 sufferers (64 handled lesions) at six European facilities had been included within the trial. 1 / 4 of the lesions had been labeled as complicated, Robocath famous.
Rouen, France-based Robocath reported 100% medical success fee (zero issues linked to the robut as much as 30 days post-procedure); geater than 95% technical success fee; and an 84.5% discount in doctor radiation publicity. The corporate is anticipated to current the ends in element later this week at EuroPCR in Paris.
The R-One robotic is particularly designed to carry out coronary angioplasties (stent implantation). From a management station shielded in opposition to radiation, the doctor makes use of joysticks to remotely management the gadgets wanted for the process, resembling guidewires, balloons, and stents. R-One was CE-marked in 2019, and is presently utilized in Europe, Africa, and China.
Along with lowering publicity to radiation, physicians utilizing the R-One robotic don’t have to put on heavy lead protecting gear in the course of the process. In keeping with Robocath, the navigation and accuracy of balloon and stent placement is improved as a result of millimeter precision of the robotic controls and since the gadgets are locked tightly in place whereas shifting by way of the vasculature.
“This was the primary medical trial in Europe that aimed to evaluate the protection and efficacy of robotic coronary angioplasty. The outcomes are extraordinarily constructive, with a technical success fee of over 95%, and a medical success fee of 100%, all of which present that angioplasties with R-One are protected and efficient for sufferers,” mentioned Eric Durand, an interventional heart specialist and co-principal investigator within the trial. “In my expertise, the common size of a robotic process (19.9 ± 9.6 min) is roughly the identical as that of a handbook process. Based mostly on these outcomes, using the robotic genuinely heralds a brand new age within the therapy of coronary heart situations, one thing that has been sorely wanted for 30 years given the numerous challenges concerned on this self-discipline, significantly the publicity to X-rays.”
One of many targets of the trial was to measure X-ray publicity to robotic operators in contrast with conventional handbook operators. This was simulated by putting a pole close to the working desk. The typical radiation dose acquired by the robotic operator was 0.2 µSv, which was 300 occasions decrease than the radiation acquired by the simulated handbook operator on the top and different components of the physique not protected by lead gear. On common, performing a coronary angioplasty robotically reduces the doctor’s publicity to X-rays by 84.5%. Robotic operators nonetheless obtain some X-ray publicity whereas manually putting the primary gadget previous to starting the robotic portion of the process; if the doctor has an assistant who locations the primary gadget, the radiation dose to the doctor is decreased by 100%.
“The extraordinarily encouraging outcomes from this examine and the studies that we’ve had from preliminary customers verify that our resolution is each appropriate and useful for sufferers and docs alike,” mentioned Lucien Goffart, CEO of Robocath. “Our plan is to proceed to reveal and quantify these advantages by way of a extremely pro-active medical program in partnership with facilities of excellence resembling Rouen College Hospital, ZNA Middelheim in Antwerp, the Neuss Clinic in Germany, and plenty of others. That is an important step in direction of higher assembly the wants and expectations of our customers. We firmly imagine that that is only the start of vascular robotics and that it’s going to proceed to develop with our present, in addition to our future, robotic generations, with which the extra complicated procedures shall be carried out. Robotics is true on the coronary heart of a sea change inside this sector. Will probably be the primary vector for integrating future technological advances by centralizing the entire process into one single interface, which can in flip be the place to begin for utilizing AI. There isn’t any doubt in my thoughts that the way forward for interventional cardiology lies in integrating robotics.”
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