Surgical teams in Europe just gained a new co-worker.
A few months after earning CE mark approval, Medtronic’s robotic-assisted surgery system—dubbed Hugo—has made its European debut.
Its first procedure on the continent was a robotic prostatectomy performed at Onze-Lieve-Vrouw Hospital in Aalst, Belgium. Alexandre Mottrie, M.D., the hospital’s head of urology, led the operation.
“With more than two decades and 4,000 robotic-assisted surgery procedures under my belt, I am intimately aware of the barriers that have kept the benefits of surgical robotics from physicians, hospitals and patients,” Mottrie said in a statement. “Now, I believe we are entering a new era filled with greater access and flexibility.”
Hugo’s trip abroad follows its premiere on the world stage in June 2021, when it was used in another minimally invasive prostatectomy at Clínica Santa Maria in Santiago, Chile. Since then, it's been seen in Chennai, India, for its first procedure in the Asia-Pacific region, and in Latin America, where the system was used for a series of gynecological procedures in Panama City.
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The robotic-assisted surgery system is designed to augment surgeons’ existing capabilities. The modular, customizable system—kept on wheels to make it portable throughout a hospital—is equipped with wristed instruments and 3D visualization tools. It can also automatically record an entire procedure, allowing the data to be used in future training sessions and facility analytics.
Additionally, as procedures around the world are completed with the help of Hugo, they’re logged in the system’s patient registry. The resulting compendium of data will be used to help Medtronic pursue regulatory approvals for Hugo across the globe.
Its CE mark arrived in October, allowing the surgical robot to be used in urologic and gynecological procedures throughout much of Europe.
Next up—if Medtronic’s 2019 plan for the system holds true—is the pursuit of FDA 510(k) clearance, after which Hugo will be expanded into soft-tissue procedures and, ultimately, offer its robotic-assisted guidance at a price similar to that of a standard manual laparoscopy.
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That timeline is already somewhat backed up, however, due to the effects of the COVID-19 pandemic and drawn-out slowdowns in the global supply chain. Last November, Medtronic CEO Geoff Martha said on an earnings call with investors that demand for the Hugo system is “higher than we can fill at this point” but that the company was hoping to ramp up production and distribution by mid-2022.
Martha said at the time that Hugo’s first use in general surgery, marking its expansion beyond robotic prostatectomies and minimally invasive gynecological procedures, could occur “any day now.” FDA submission, meanwhile, will be on the docket “very soon,” he added.