TransEnterix Surgical received FDA clearance for its Senhance System, a new robotically-assisted surgical device, or RASD, designed to facilitate minimally invasive surgery, according to a press release from the FDA.
“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” Binita Ashar, MD, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, said in the release. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.”
TransEnterix Surgical conducted a clinical study of 150 patients who underwent various gynecological operations with the Senhance System and compared the outcomes with 8,000 gynecological operations performed with other RASD technology from eight research publications. Additionally, the company submitted results from 45 patients who underwent colorectal procedures, which were compared with previous research publications.
According to the release, the FDA concluded that the Senhance System demonstrated substantial equivalence to the da Vinci Si IS3000 (Intuitive Surgical) device for gynecological and colorectal procedures. – by Talitha Bennett