New Robotic System Completes Surgical Procedures in Humans

Clinical trial in India a complete success

CMR Surgical Ltd, the company behind the next-generation surgical robotic system Versius®, announced last month that it has successfully completed its first series of surgical procedures in humans.

Thirty laparoscopic procedures were completed as part of a clinical trial at Deenanath Mangeshkar Hospital & Research Center in Pune, India, by Consultant Oncologist and General Surgeon Dr. Dhananjay Kelkar and his team. The surgeries consisted of minor, intermediate and major gynecological and upper gastrointestinal (GI) procedures. No adverse events were reported as a result of the use of Versius® after a 30-day follow up.

 “As the first surgeon to conduct a laparoscopic procedure in a clinical setting using Versius, I can say that the system has been shown to be highly effective and has significant potential for bringing minimal access surgery to patients here in India, and around the world.  The Versius® Surgical Robotic System is flexible and fits easily into our busy operating environment. We have a high demand for surgical care and are committed to bringing the most innovative technologies to our patients,” commented Dr. Dhananjay Kelkar.

 “This first-in-human series is a significant milestone in bringing Versius to operating theatres around the world. These initial results are positive and we look forward to further advancing our mission to bring the benefits of minimal access surgery to everyone who needs it. This series is part of our drive for the responsible introduction of surgical robotic systems that puts safety and effectiveness above all else,” commented Mark Slack, Chief Medical Officer at CMR Surgical.

 The Versius Clinical Study is a single-center, prospective cohort study. The study design is to evaluate the safety and performance of Versius in robotically-assisted surgery across a range of abdominal and pelvic surgical procedures.  The primary endpoint of the study is the rate of unplanned conversion of procedures to other minimal access surgery or open surgery. 

 The results of this study will be included in the CMR Surgical Registry. This is a prospective real-world data registry, set up to gather clinical performance and safety data on all surgical procedures conducted with the Versius® Surgical System in all geographical locations. In addition to providing post-market safety data, it will also allow monitoring of individual surgical performance. 

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