Distalmotion has received 510(k) clearance from the US Food and Drug Administration (FDA) for ventral hernia repair with its Dexter robotic surgery system.
The approval is backed by information from the Robotic Minimally Invasive Ventral Hernia Repair (RAVEN) study.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Dexter, which has held CE marking since 2022 for use in general, gynaecologic and urologic surgery, has already been utilised in thousands of hernia repair procedures across Europe.
The latest FDA clearance authorises the use of Dexter in ventral hernia repairs, one of the most common outpatient general surgical procedures in the US.
With this clearance, Dexter is permitted in the four highest-volume soft tissue ambulatory procedures in the US, notably hysterectomy, cholecystectomy, inguinal hernia repair, and ventral hernia repair.
Designed specifically for ambulatory surgery centres (ASCs) that require a compact and mobile solution, Dexter offers distinctive access for surgeons at the bedside and is compatible with all visualisation systems due to its open architecture.
Distalmotion cited figures showing that these procedures collectively account for more than three million cases annually, with ventral hernia repair alone comprising over 600,000 operations, more than 75% of which occur in ambulatory settings.
Distalmotion CEO Greg Roche said: “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 programmes, allowing them to focus on providing patient-centric care to more members of their communities.”
Distalmotion states more than 4,000 patients have been treated with Dexter.
In Europe, it is intended for adult use in urologic, general, and gynaecologic laparoscopic procedures.
In the US, it is cleared for adult laparoscopic inguinal and ventral hernia repair, cholecystectomy, total benign hysterectomy (including salpingo-oophorectomy), and sacrocolpopexy.
