RESEARCH TRIANGLE PARK – TransEnterix recently changed its name to Asensus and on Wednesday the firm best known for robitic surgery disclosed what could be a major victory for the company: The FDA has approved its Senhance Surgical System for wider use in general surgery.

The news sparked an immediate 30% share in Asensus (NYSE: TRXC) shares in pre-market trading.

“Many of the procedures we perform in general surgery require complex reconstruction throughout a wide surgical field,” said Dr. Sabino Zani, an Assistant Professor of Surgery at Duke University who was an investigator in the clinical studies submitted to the FDA in seeking expanded use. His statement was included in the Asensus announcement. “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.”

The Senhance system, which the company says utilizes “augmented intelligence through machine learning” to improve patient outcomes, has been available for several years and upgraded but its use has been limited.

“The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology,” said Anthony Fernando, CEO of Asensus. “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 utilized in over 2.7 million general surgical procedures performed in the US annually.”

According to the company, the platform “goes beyond” other robotic surgical systems, utilizing “haptic feedback, eye-tracking camera control, and 3D visualization.” It also includes “he smallest instrument available in the world on a robotic surgical platform.”

It is “intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use,” the company adds.