Robocath has announced the conclusion of its R-Evolution clinical study in Europe, which was aimed at assessing the safety and efficacy of the R-One robotic assistance platform for percutaneous coronary intervention (PCI) procedures.
Sixty-two patients across six European hospital centres participated: the University Hospitals in Rouen and Caen and Clinique Pasteur, Toulouse, France, the ZNA Middelheim Hospital in Antwerp, Belgium, the Maasstad Clinic in Rotterdam, The Netherlands, and the National Interventional Cardiac Surgery Institute in Luxembourg. The last patient was enrolled on October 8, 2021, at the Caen University Hospital Center. Full results of the study are due in May 2022 and will be presented at the EuroPCR conference.
Eric Durand, interventional cardiologist at the Rouen University Hospital Center and joint principal investigator for the study, said: “I feel honoured to have had the chance to be joint principal investigator of the R-Evolution clinical study. I have been involved in the development of this robotic platform since the beginning, with Prof Remi Sabatier from the University Hospital of Caen. I was able to participate in the development, preclinical studies and first-in-human procedures with R-One.
“The robot is intuitive, easy to understand and offers a very fast learning curve. Beyond that, as well as being more precise than working by hand, it also opens the door to new manoeuvres. These clinical cases have strengthened my belief that vascular robotics is a necessary development in our sector and that it will allow us to offer high-quality treatment to all patients within a work environment that is far superior, for both physicians and their teams.”
Jean Fajadet, interventional cardiologist at the Clinique Pasteur in Toulouse and joint principal investigator for the study, said: “Robotics is, in all likelihood, the future of interventional cardiology; there is no doubt in my mind that this study will prove that. Vascular robotics now allows us to position a stent with millimetre precision and place it safely, as the robot holds and guides the instruments throughout the procedure. The movement is fluid and usage is intuitive. The system offers overall working conditions that are far more comfortable than operations carried out by hand and completely protects the physician from X-rays.
“Robotics will eventually enable us to complete more complex procedures and will be the main vector for global integration and transformation in cath labs. This will enhance healthcare sites’ attractiveness by improving the quality of care provided to patients. I am delighted to be one of the first interventional cardiologists in the world to work with this significant technological advance in our sector.”
Philippe Bencteux, president and founder of Robocath, added: “The conclusion of the R-Evolution study marks the end of years of hard work and investment by everyone involved and I am grateful to all of them. We are genuinely on the cusp of a new era in vascular medicine. As the founder of the company, I am delighted to see our vision coming to life.”
Lucien Goffart, CEO of Robocath concluded: “We have once again reached a crucial milestone in our company’s history. This is the result of a vibrant and productive partnership between the hospital centers and the Robocath staff, who have worked incredibly hard against the backdrop of the current medical context. They all have my most sincere thanks. Vascular robotics has immense potential for use. We now plan to capitalise further on the clinical experience with our product to accelerate our growth in Europe by opening a Europe-wide observational registry.”