Robocath has announced the completion of patient enrolment in the first-in-human clinical study evaluating its next-generation robotic system for percutaneous coronary intervention (PCI).
Conducted at the Centre Cardiologique du Nord (CCN) in Saint-Denis, France and led by principal investigator Mohammed Nejjari alongside Franck Digne, the study assessed the feasibility and safety of robot-assisted percutaneous coronary intervention (RA-PCI) using Robocath’s next-generation system in patients with coronary artery disease.
“Completing enrolment in this first-in-human study is a defining moment in the field of interventional cardiology,” said Nejjari. “For the first time, we have demonstrated that robotic assistance can be safely and reliably applied to the full spectrum of coronary lesion complexity, including the most challenging anatomies. This is not a glimpse into the future: it is the future, starting now.”
Robocath’s second-generation robot leverages the clinical and technological experience from its first robotic platform, now used in centres worldwide, and integrates advanced capabilities such as multi-device handling to support increasingly complex coronary procedures.
The study includes 20 patients (≥ 18 years old) with coronary artery disease, primarily complex cases seen in real-world catheterisation laboratory practice. They were stratified by coronary lesion complexity across three subgroups: six patients with type A/B1 lesions; seven patients with type B2 lesions; and seven patients with type C lesions.
To date, no safety concerns have been reported in connection with the use of Robocath’s system. Technical outcomes observed across all lesion subgroups—including complex type B2 and type C anatomies—are considered promising.
“Congratulations to Mohammed Nejjari and the CCN team for completing full-patient enrolment in this study, a worldwide first-of-its-kind achievement,” said Philippe Bencteux, CEO of Robocath. “This is a key milestone in validating our unique technology, designed to transform PCI management across all levels of complexity. We remain committed to advancing coronary artery disease care, the world’s leading cause of death, while improving the daily practice of healthcare professionals.”
According to the company, these early findings support the potential of Robocath’s next-generation system to address a broad spectrum of coronary artery disease presentations, including patients with challenging anatomical characteristics. Full data analysis and detailed results will be presented in the near-term in forthcoming scientific communications.
