Distalmotion Secures FDA Clearance for DEXTER Robotic System in Ventral Hernia Repair

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Distalmotion, the global MedTech company expanding access to robotic surgery in outpatient sites of care, announced it has received US Food and Drug Administration 510(k) clearance for ventral hernia repair with its DEXTER Robotic Surgery System. The clearance was supported by data from the Robotic minimAlly invasive Ventral hErNia repair (RAVEN) Study. CE-marked since 2022 in general, gynecologic, and urologic surgery, DEXTER has real-world clinical experience in thousands of hernia repairs in Europe.

“Ventral hernia repair is one of the highest-volume outpatient general surgery procedures,” said Dr. Jeffrey Berndtson, General Surgeon, Northtowns Ambulatory Surgery Center. “This ventral hernia repair approval allows us to use DEXTER to treat almost 40% more patients robotically in our surgery center, which further optimizes the efficiency of our ASC schedule.”

This clearance allows DEXTER to be used in the top four highest volume soft tissue ambulatory procedures in the US, with a combined total annual volume of more than 3 million¹: cholecystectomy, hysterectomy, inguinal hernia repair, and ventral hernia repair. Ventral hernia repair represents a major outpatient opportunity with greater than 600,000 performed each year, of which more than 75% are ambulatory². Together, these indications significantly expand the number of patients benefitting from robotic surgery in a patient-preferred ambulatory surgery center (ASC) setting. For ASC administrators and surgeons, DEXTER supports adding or expanding general surgery and gynecology service lines for efficient, cost-effective outpatient care.

“Securing FDA clearance for ventral hernia repair completes our core outpatient portfolio and marks a major strategic milestone for Distalmotion,” said Greg Roche, CEO of Distalmotion. “Until DEXTER, ASCs did not have a surgical robot that fit their physical and economic realities. With DEXTER, they avoid costly infrastructure changes, additional sterile processing equipment, significant staffing requirements, and large inventories needed to support high-volume robotic programs, allowing them to focus on providing patient-centric care to more members of their communities.”

Purpose-built for ASCs with a small and mobile footprint, DEXTER provides unique surgeon bedside access and open architecture compatibility with all visualization systems as well as an efficient learning curve for setup and use.

With more than 4,000 patients treated with DEXTER, Distalmotion continues to advance its mission to expand access to robotic surgery across high-volume outpatient procedures.