Distalmotion’s DEXTER robot cleared by the FDA for ventral hernia repair

Distalmotion, the Lausanne-based medtech company, has received FDA 510(k) clearance for ventral hernia repair with its DEXTER Robotic Surgery System, completing its portfolio for the four highest-volume outpatient soft tissue procedures in the United States.

Distalmotion, a medtech company headquartered in Lausanne, has received 510(k) clearance from the US Food and Drug Administration 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.

The clearance allows DEXTER to be used in the four highest-volume soft tissue ambulatory procedures in the United States, representing a combined annual volume of more than three million cases: cholecystectomy, hysterectomy, inguinal hernia repair and ventral hernia repair. Ventral hernia repair alone accounts for more than 600,000 procedures each year, of which more than 75 percent are ambulatory.

DEXTER is a soft tissue surgical robot designed for ambulatory surgery centers, with a small, mobile footprint that integrates into operating rooms of any size without structural modifications. Its sterile console positions the surgeon close to the patient for bedside access and allows transitions between laparoscopic and robotic techniques, while its open architecture ensures compatibility with existing visualization systems and other operating room technologies.

More than 4,000 patients have been treated with DEXTER to date. The system is commercially available in the United States and Europe, and the company operates a US office in Cleveland, Ohio alongside its Swiss headquarters.