Robocath R-One Results From European Multicenter R-EVOLUTION Study Presented

May 18, 2022—Robocath, a developer of robotic platforms for the treatment of vascular diseases based in Rouen, France, announced results of its R-EVOLUTION clinical study. The findings showed that coronary angioplasties using the company’s R-One robot are safe and effective for patients, while also improving the working conditions for the interventional cardiologist by drastically reducing exposure to x-rays.

According to the company, the R-One medical robot is designed to perform coronary angioplasties from a comfortable control station shielded against radiation. The physician uses joysticks to remotely control the procedure devices, such as guidewires, balloons, and stents. R-One received CE Mark approval in 2019 and is currently used in Europe, Africa, and China.

The R-EVOLUTION study results were presented during the “Robotic PCI: Evolution or R-Evolution” session at the EuroPCR 2022 conference held May 17-20 in Paris, France.

Robocath reported that the R-EVOLUTION trial was a prospective, nonrandomized, single-arm clinical study that assessed the safety and efficacy of the R-One robot when used for coronary angioplasties. A total of 62 patients (64 treated lesions) at six European centers were included in the trial. One quarter of the lesions were classified as complex under the American College of Cardiology/American Heart Association classification.

The six European hospital centers included CHU Rouen in Rouen, France; CHU Caen in Caen, France; Clinique Pasteur in Toulouse, France; ZNA Middelheim in Antwerp, Belgium; Maasstad clinic in Rotterdam, the Netherlands; and the National Interventional Cardiac Surgery Institute in Luxembourg. Final patient enrollment in the study was initially planned for September 2020; however, because of the pandemic, the last patient was enrolled on October 8, 2021, at the University Hospital of Caen.

Professor Eric Durand, MD, an interventional cardiologist at CHU Rouen, served as Coprincipal Investigator in the trial. In Robocath’s press release, Prof. Durand stated, “This was the first clinical trial in Europe that aimed to assess the safety and efficacy of robotic coronary angioplasty. The results are extremely positive, with a technical success rate of over 95% and a clinical success rate of 100%, all of which show that angioplasties with R-One are safe and effective for patients. In my experience, the average length of a robotic procedure (19.9 ± 9.6 min) is roughly the same as that of a manual procedure. Based on these results, the use of the robot genuinely heralds a new age in the treatment of heart conditions, something that has been sorely needed for 30 years given the significant challenges involved in this discipline, particularly the exposure to x-rays.”

Investigator Professor Stefan Verheye, MD, Interventional Cardiologist at ZNA Middelheim, added, “For the first time in my career I was able to operate while sitting comfortably, without having to wear a lead apron and completely shielded from x-rays. I also benefited from the exceptional visual layout, with the display right next to the radioscopy monitors.”

Robocath advised that one of the goals of the trial was to measure x-ray exposure to robotic operators compared with traditional manual operators. This was simulated by placing a pole near the operating table.

The average radiation dose received by the robotic operator was 0.2 µSv, which was 300 times lower than the radiation received by the simulated manual operator on the head and other parts of the body not protected by lead gear.

The company stated that on average, performing a coronary angioplasty robotically reduces the physician’s exposure to x-rays by 84.5%. Robotic operators still receive some x-ray exposure while manually placing the first device before beginning the robotic portion of the procedure; if the physician has an assistant who places the first device, the radiation dose to the physician is reduced by 100%.

Prof. Verheye explained, “These working conditions are much safer and more comfortable than operating by hand, which means I can focus all my attention on my technique. The robot also allows me to position a stent with millimeter precision and place it safely, as the system always locks the devices in place. It is easy to learn and intuitive to use. I am delighted to continue assessing the robot routinely in the context of an observatory registry.”

Jean Fajadet, MD, a study Coprincipal Investigator with Clinique Pasteur, concluded, “Robotic coronary angioplasty marks a watershed moment. It is, at this time, the only viable and long-term answer to procedures becoming increasingly long and complex, and requiring high precision, expertise and experience in interventional cardiology. While it is revolutionary, the system uses the same devices as those currently used and is compatible with all imaging systems, which should make uptake easy among all physicians.” Dr. Fajadet is current Vice Chairman at EuroPCR and served as the session host for the discussion of the R-EVOLUTION findings at EuroPCR.