CMR Surgical received marketing authorization from the FDA for its Versius Surgical System. It's the first multiport, soft tissue general surgical robotic-assisted device to earn authorization through the agency's De Novo application process.

It's indicated for adult patients 22 years of age and older who are undergoing cholecystectomy. The system works by controlling Versius Surgical endoscopic instruments and it has already been used during more than 26,000 surgical procedures in Europe, Latin America, Asia, Middle East and Africa.

"Surgical robotics is important for helping surgeons to perform keyhole procedures, and the benefits that brings to patients when compared to open surgery — quicker recovery, reduced pain, and smaller wounds, and thereby a reduced risk of site infection," Mark Slack, chief medical officer and co-founder at CMR Surgical, told HCB News. "We expect more and more of these procedures to be done robotically if surgeons have a versatile system with favorable economics that can fit into virtually any care setting."
A study published in the Journal of Surgical Research found that of 9.8 million inpatient major operating room procedures conducted in the U.S. in 2017, only 2.5% were robotic assisted. Although the U.S. is a mature market for surgical robots, there have been few options for hospitals looking to start a soft tissue robotics program.

Slack explained that there have been a limited number of surgical systems on the market due to a variety of regulatory reasons. With this FDA authorization, hospitals and patients will now have greater access to robotic-assisted surgery.

The Versius Surgical System was designed to mimic the human arm, allowing for optimized port placemat. It also features 3D HD vision and gives the surgeon a choice of ergonomic working positions.

"Manual laparoscopic surgery can be highly challenging, with a reduced range of movement in instrumentation in addition to being physically demanding — with surgeons often needing to place themselves in awkward positions over a patient for hours on end," said Slack.

The system is compact and modular, meaning it can integrate into almost any operating room to perform cholecystectomy procedures, and can be easily moved between departments. It's designed to fit into a hospital's existing workflow.

Versius also gives hospitals access to a suite of digital apps that provide real-time insights to help them improve proficiency and optimize their surgical robotics programs. CMR Surgical plans to start a global metric-based training program, which will include the Versius Trainer and the Versius eLearning platform.

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