CMR Surgical said today that it has successfully completed the first-in-human procedures with its Versius surgical robotic system as part of a clinical trial in Pune, India.
A total of 30 procedures were performed by Dr. Dhananjay Kelkar and their team at the Deenanath Mangeshkar Hospital & Research Center,
The U.K.-based company said that the Versius robotic platform’s design is inspired by the human arm, and is intended to be affordable and transportable due to its small size and modular design.
The first-in-human procedures included minor and major gynecological and upper gastrointestinal procedures, CMR Surgical said. No adverse events were reported related to the Versius system at 30-days post procedure.
“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 said in a prepared statement.
CMR Surgical said that following the completion of its first-in-human studies, it will work with surgeons and hospitals to introduce its Versius surgical robotic system globally. The company said that it won CE Mark approval in the European Union in March.
“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,” chief medical officer Mark Slack said in a press release.
Last September, CMR Surgical unveiled its portable Versius robotic surgical platform, designed for use in minimal-access procedures.