Mark Slack
Chief Medical Officer, CMR Surgical
“CMR has collected a wealth of system and clinical data which have provided us with meaningful insights about the safety, effectiveness and quality of Versius, and has played a vital role in preclinical and clinical research investigating the responsible introduction of the system across a wealth of surgical specialties.”
In the beginning, CMR Surgical set out to make minimal access surgery more accessible and transform how surgery was performed around the world with Versius. Fast-forward to today, and Versius has now been used to perform over 10,000 surgical procedures globally. This is a significant clinical milestone for CMR, that firmly aligns with our mission from the outset to create a comprehensive collection of meaningful clinical data to support clinical excellence. Not only this, but the news also demonstrates the safety and efficacy of the system, with thousands more patients around the world having now received the benefits of minimal access surgery with Versius. But how did we get here? And how have we successfully built, a robust, world-class clinical registry with data from around the world?
The 10,000 cases that have been completed using Versius span 130 complex and benign procedure types from mouth to pelvis, including colectomies, hysterectomies, hernia repairs and lobectomies. From these cases, CMR has collected a wealth of system and clinical data which have provided us with meaningful insights about the safety, effectiveness and quality of Versius, and has played a vital role in preclinical and clinical research investigating the responsible introduction of the system across a wealth of surgical specialties. The clinical data collected from these procedures has been entered into CMR’s clinical registry – one of the world’s first clinical registries for surgical robotics as part of the Versius® digital ecosystem, recording real world data from Versius® procedures to ensure safety and help surgeons and hospitals to drive improved surgical standards.
CMR’s clinical registry is a prospective, multi-center, international, observational registry. The registry facilitates continual monitoring of key performance indicators, such as operative time and rate of conversion to a different operating modality, with the aim of improving patient safety through early intervention where required.[i] The analysis of registry data, coupled with system data collected by Versius itself, has enabled us to proactively identify any signs of device issues where additional maintenance may be required, and instances where targeted training may be needed to support individual surgeons.
Since its inception, the registry has provided unparalleled insights into the way surgeons perform surgery, and has informed a number of peer-reviewed clinical publications from surgeons around the world on the use of Versius. The clinical registry is a consequence of our commitment to post-market surveillance as part of the IDEAL Collaboration’s Framework for the responsible implementation of new surgical therapeutic intervention.[ii] The IDEAL Collaboration is an initiative developed by a group of research methodologists and surgeons to improve the quality of research in surgical innovation and complex interventions to build up a robust evidence base about new procedures and devices. The IDEAL principles, and corresponding framework, are globally recognised guidance on how to introduce complex technologies ethically. The IDEAL Framework describes the stages through which surgical therapy innovation normally passes.
The final two stages, Assessment and Long-term follow-up underpin the ongoing role the registry will play in the continued clinical success of Versius – an accessible clinical registry that is continually added to, and drawn from, as Versius case numbers continue to grow, supporting the evidence-based, data-driven approach we take to the work we do as a company. This is demonstrated nowhere better than in our metric-based training programme. Developed in conjunction with surgical teams, the seven-step programme draws on cutting-edge technology such as our Versius Trainer, Versius eLearning platform and Versius Virtual Reality that forms part of our wider digital ecosystem, and the data-driven metrics it collects to measure the completion of key competencies at each stage of the training pathway to ensure standardisation in surgical skills, and support personalised feedback – supporting shorter learning curves and thereby training time and costs for teams to become proficient. Access to this data can help us work towards standardising surgery, supporting our ultimate goal of improving surgical outcomes for patients worldwide.
References
[i] Soumpasis I, Nashef S, Dunning J, et al Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System. BMJ Surgery, Interventions, & Health Technologies 2023;5:e000144. doi: 10.1136/bmjsit-2022-000144
[ii] Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019 Feb;269(2):211-220. doi: 10.1097/SLA.0000000000002794. PMID: 29697448.