Asensus Surgical , formerly TransEnterix, announced that it won expanded FDA clearance for its Senhance surgical system.
Research Triangle Park, N.C.–based Asensus Surgical’s Senhance surgical system, which it touts as the first-of-its-kind digital laparoscopic platform that leverages augmented intelligence to provide strong performance and positive patient outcomes through machine learning, now has FDA clearance for indication expansion in general surgery, according to a news release.
The surgical robotic system provides assurance through haptic feedback, eye-tracking camera control and 3D visualization. Asensus also touts Senhance as the first such platform offering 3 mm instruments, which are the smallest available on a robotic surgical platform.
Senhance’s U.S. indication is for controlling laparoscopic instruments for visualization and endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction.
It is intended for general laparoscopic surgical procedures and laparoscopic gynecological surgery and only for adult use. In contrast, trained physicians must use it in an operating room environment under the instructions for use.
An expanded indication for Senhance follows last month’s news that the company would change its name from TransEnterix to Asensus Surgical and introduce a new surgery category. The company seeks to enter a new era of performance-guided surgery. It’s focusing on digitizing the interface between the surgeon and the patient to unlock clinical intelligence that may enable superior outcomes and potentially a new standard of surgery.
“The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology,” Asensus Surgical president & CEO Anthony Fernando said in the release. “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 U.S. annually.”
“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.”
Senhance US Indication for Use
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System 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.
About Asensus Surgical, Inc.
Asensus Surgical, Inc. is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery. This builds upon the foundation of Digital Laparoscopy with the Senhance® Surgical System powered by the Intelligent Surgical Unit™ (ISU™) to increase surgeon control and reduce surgical variability. With the addition of machine vision, augmented intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. Learn more about Performance-Guided Surgery and Digital Laparoscopy with the Senhance Surgical System