TransEnterix Inc.'s Senhance Ultrasonic system, part of the company's robotic surgery platform for use in minimally invasive surgeries, has been approved by the U.S. Food and Drug Administration.
The Morrisville, N.C.-based medical device maker said in a Jan. 15 press release that the addition of ultrasonic technology was a significant expansion to its Senhance system, which is the first abdominal robotic surgery platform to receive FDA clearance since 2000.
The Senhance system itself is already cleared in the U.S. for laparoscopic colorectal, gynecological, inguinal hernia and gallbladder removal surgery. With the FDA nod, the Senhance Ultrasonic system is now available in the U.S., as well as all countries that accept a CE Mark designation for the product.
TransEnterix said advanced energy devices, including ultrasonic devices, are critical tools for surgeons in minimally invasive surgery as they deliver controlled energy to effectively ligate and divide tissue, while minimizing thermal injury to surrounding areas.