CMR Surgical Ltd, the company behind the next-generation surgical robotic system Versius, announced 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 gynaecological 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,” Dr. Dhananjay Kelkar says.
“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,” Mark Slack, Chief Medical Officer at CMR Surgical, says.
The clinical trial was conducted in line with CMR Surgical’s collaboration with the IDEAL framework which provides an international benchmark for each stage of the surgical innovation process, including clinical trials. The first-in-human series is being carried out under internationally recognised clinical trial protocols as set out by Good Clinical Practice (GCP).
