Distalmotion Expands DEXTER Robotic Surgery Portfolio with FDA 510(k) Clearance for Ventral Hernia Repair

Distalmotion, a global MedTech company focused on expanding access to robotic surgery in outpatient care settings, has received US Food and Drug Administration (FDA) 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 and expands DEXTER’s use across the four highest-volume soft tissue ambulatory procedures in the United States: cholecystectomy, hysterectomy, inguinal hernia repair, and ventral hernia repair.

Ventral hernia repair represents more than 600,000 procedures annually in the US, with more than 75% performed in ambulatory settings. The expanded indication allows more patients to access robotic surgery in ambulatory surgery centers (ASCs).

Dr. Jeffrey Berndtson, General Surgeon at Northtowns Ambulatory Surgery Center, stated:

"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."

Greg Roche, CEO of Distalmotion, stated:

"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."

Purpose-built for ambulatory surgery centers, DEXTER features a compact mobile footprint, open architecture compatibility with visualization systems, and wristed single-use robotic instruments designed to simplify robotic surgery workflows.

With more than 4,000 patients treated using DEXTER, Distalmotion continues expanding robotic surgery access across high-volume outpatient procedures.