TransEnterix has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Senhance ultrasonic system.
Image: FDA’s Center for Devices and Radiological Health in Silver Spring, Maryland. Photo: Courtesy of The US Food and Drug Administration.
TransEnterix stated that advanced energy devices such as ultrasonic devices are considered to be versatile systems and can be important for surgeons in minimally invasive surgery. These instruments can deliver controlled energy to ligate and divide tissue and reduce thermal injury to surrounding structures.
With FDA approval, the Senhance ultrasonic system will now be available in the US, along with all countries that accept CE Marking.
TransEnterix president and CEO Todd Pope said: “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.
“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 US.”
The Senhance system is claimed to be the first new abdominal robotic surgery platform to receive FDA clearance since 2000 and is the only digital laparoscopic surgical platform to provide security of haptic force feedback. This allows surgeons to feel the forces the instruments generate while handling delicate tissue.
It also offers reusable instruments that keep per-procedure costs similar to that of traditional laparoscopic surgeries, along with 3mm instruments for microlaparoscopic procedures, enabling virtually scarless incisions for patients.
These technologies are exclusive to Senhance and the company claims to have designed them to pave the way for future robotic surgery, while keeping the per-procedure costs low and ultimately healthcare costs in general for hospitals and patients.
Florida Hospital Celebration Health gynecologic surgery chief Steven D. McCarus said: “The addition of ultrasonic technology is a significant expansion of the Senhance system capability preferred by many surgeons during complex procedures.
“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.”
In the US, the Senhance system has been cleared for laparoscopic colorectal, gynecological, inguinal hernia and cholecystectomy (gallbladder removal) surgery.