Asensus Surgical digital laparoscopic device gets FDA nod for use in general surgery

Asensus Surgical referred to the expanded use of its Senhance Surgical System as a "major milestone" in the company's journey

The arms of Asensus Surgical's Senhance Surgical System (Credit: Asensus Surgical)

Asensus Surgical has received an additional FDA clearance for the Senhance Surgical System, which allows for indication expansion in general surgery in the US.

The company – which previously went by the name TransEnterix – was already approved for minimally invasive surgeries performed via laparoscopy, including gynaecological procedures, colorectal surgery, cholecystectomy, and inguinal hernia repair.

But this extended clearance from the US regulator means it may be used in general surgery too, including in emergency situations.

Anthony Fernando, Asensus Surgical President and CEO said: “The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology.

“General surgery is, by far, the largest area of manual laparoscopy which can benefit from the precision and insight of Performance-Guided Surgery.

“The indication expansion allows Senhance to be used in many high-value, complex reconstructive surgeries such as those used to treat reflux and obesity.

“Including previous indications granted, the Senhance Surgical System can now be utilised in over 2.7 million general surgical procedures performed in the US annually.”

The platform aims to enhance surgical outcomes in laparoscopic procedures using haptic feedback, eye-tracking camera control, and 3D visualisation to allow surgeons to operate digitally with greater precision.

Asensus Surgical also claims it is the first platform to offer 3mm instruments – the smallest instrument available in the world on a robotic surgical platform.

“Many of the procedures we perform in general surgery require complex reconstruction throughout a wide surgical field,” said Dr. Sabino Zani, assistant professor of surgery at Duke University and an investigator in the clinical studies submitted for indication expansion.

“Senhance can now be seen as a widely applicable tool for general surgeons across the broad range of procedures that may be performed from deep in the pelvis to the upper abdomen.”