TransEnterix Receives FDA 510(k) Clearance for Senhance Ultrasonic System
Posted on January 15, 2019 by Medtech[y] Staff
We first caught wind of the FDA clearance for the TransEnterix Ultrasonic System via the TRXC Stock Group on Facebook and now TransEnterix shared an official announcement this morning.
“The addition of ultrasonic technology is a significant expansion of the Senhance system capability preferred by many surgeons during complex procedures,” said Dr. Steven D. McCarus, MD, FACOG, Chief of Gynecologic Surgery at Florida Hospital Celebration Health. “Combining advanced energy tools with the precision, control, haptics and ergonomics of the Senhance digital interface may allow many surgeons to confidently use this technology across the broadest range of pathology and patients.”
What to know:
- In the U.S. the Senhance System is cleared for laparoscopic colorectal, gynecological, inguinal hernia and cholecystectomy (gallbladder removal) surgery.
- 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.
“Advanced energy devices are used within a high percentage of cases across a wide range of procedures, which make them a critical tool for laparoscopic surgeons,” said Todd M. Pope, TransEnterix president and CEO. “We believe the addition of the Senhance Ultrasonic System is significant and broadens the attractiveness of the Senhance platform and digital laparoscopy for surgeons in the U.S.”