Producer of cardiovascular robotic systems for the treatment of vascular diseases, Robocath, has announced that its first robotic solution has met all primary efficacy and safety endpoints in its first pre-clinical study.

The R-OneTM system is designed to assist with interventional cardiology by providing physicians with precise and reliable actions during procedures. The system utilises a radio-protected control unit, for its articulated support arm, which physicians use to remotely control instruments in the vascular system.  

A prospective, randomised study evaluated the system’s efficacy and safety compared to a manual procedure of percutaneous coronary intervention (PCI). Taking place from October – November 2017, 21 arteries were stented with robotic assistance and 21 were stented manually. Following the procedures, patency and flow were analysed at 30 days and 24 arteries went through histopathological analysis.

Results show that the R-OneTM system achieved 100% technical success, no major adverse cardiac events, total protection from X-rays for the operator and no arterial damage.

Philippe Bencteux , president and founder of Robocath, said: “This study demonstrates how safe, intuitive and easy to use our solution is with only a one-minute difference in procedure duration between the two groups. R-OneTM will bring huge benefits during Percutaneous Coronary Interventions (PCI) to both patients, in terms of intervention precision, and to operators, with increased comfort. We would like to thank Pr. Eric Durand, Dr. Jean Fajadet and Pr. Remi Sabatier for their participation in this trial which represents a strategic milestone for the company.”

The system is expected to be commercially available in Europe and the Middle East by the end of the year.