Digital laparoscopic system gets 510(k) clearanceMarch 5, 2019
TransEnterix, Inc announced the company received FDA 510(k) clearance for its Senhance Ultrasonic System.
The Senhance System is a new abdominal robotic surgery platform to receive FDA clearance since 2000 and is the first digital laparoscopic surgical platform to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue.
It uses reusable instruments that help keep per-procedure costs similar to that of traditional laparoscopic surgeries, as well as 3 mm instruments for microlaparoscopic procedures that enable virtually scarless incisions for patients.
Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue and minimize thermal injury to surrounding structures.
In the US, the Senhance System is cleared for laparoscopic colorectal, gynaecological, inguinal hernia and cholecystectomy surgery.