FDA OKs Distalmotion’s Dexter Robot for Ventral Hernia Repair

Distalmotion has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for ventral hernia repair with its Dexter robotic surgery system.

The FDA nod was supported by data from the Robotic minimAlly invasive Ventral hErNia repair (RAVEN) study. Dexter has been CE marked in Europe since 2022 in general, gynecologic, and urologic surgery and boasts real-world clinical experience in thousands of hernia repairs in Europe.

The clearance expands Dexter’s use to four high-volume soft-tissue procedures—cholecystectomy, hysterectomy, inguinal hernia repair, and ventral hernia repair—with more than three million procedures performed annually in the U.S. The expanded indications broaden access to robotic surgery in ambulatory surgery centers (ASCs) and support general surgery and gynecology service-line growth.

The surgical system was purpose-built for ASCs with a small, mobile footprint. It offers surgeon bedside access and open architecture capability with all visualization systems, according to the company.

In June, Dexter earned FDA clearance for gynecologic procedures including sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection.

Comments from Distalmotion and clinicians

Greg Roche, CEO: “Securing FDA clearance for ventral hernia repair completes our core outpatient portfolio and marks a major strategic milestone for 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.”

Dr. Jeffrey Berndtson, General Surgeon, Northtowns Ambulatory Surgery Center: “Ventral hernia repair is one of the highest-volume outpatient general surgery procedures. 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.”