Robocath demonstrates safety and efficacy of R-One

100% technical success and no MACE[1] scored in first pre-clinical randomized trial

Robocath, a company that designs, develops and commercializes cardiovascular robotic systems for the treatment of vascular diseases, announces today during the EuroPCR congress that its first robotic solution, R-One^TM, met all its primary efficacy and safety endpoints in the first pre-clinical study.

The prospective, randomized, controlled, multi-operator study evaluated the efficacity and safety of the robotic system compared to a manual procedure. Results showed that there was no significant difference between both procedures for all the primary endpoints and that R-One^TM achieved:

• 100% technical success
• No Major Adverse Cardiac Events (MACE)
• Total protection from X-rays for the operator
• No arterial damage

Philippe Bencteux, MD, 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-One^TM will bring huge benefits during 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.”

R-One^TM is expected to be commercially available at the end of the year in Europe and the Middle East.

ABOUT THE PRE-CLINICAL STUDY

The pre-clinical prospective, randomized, controlled, multi-operator study was designed to demonstrate the  non-inferiority of R-one^TM compared to manual percutaneous coronary intervention (PCI) in a porcine model. In total, 42 arteries were stented either manually (21) or with robotic assistance (21); 24 arteries were analyzed for patency and flow at 30 days and 24 arteries went through histopathological analysis. Endpoints included technical success and MACE.

The study started on October 17, and ended on November 14, 2017.

The study was conducted at IMM-R in Paris (France) with the three following operators:

• Eric Durand, head of the cardiovascular department at Rouen University Hospital (France);
• Jean Fajadet, co-director of the cardiovascular disease department at the Clinique Pasteur in Toulouse (France) and co-director of EuroPCR Congress;
• Rémi Sabatier, interventional cardiologist at Caen University Hospital (France).

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^[1] Major Adverse Cardiac Events