Authors: Gustavo Romero-Velez, MD; David M Pechman, MD
TransEnterix received FDA approval for Senhance Ultrasonic System on January 15, 2019.
The Senhance Ultrasonic System is an advanced energy device that couples with Senhance robotic surgery platform. With the Senhance Surgical System, TransEnterix strives to improve minimally invasive surgery by digitizing the interface between the surgeon and patient. The system allows for precise control and offers surgeons the benefit of haptic force feedback. It is the first robotic surgical platform that offers reusable instruments and 3mm instruments for microlaparoscopy. The addition of ultrasonic energy to the platform will improve the versatility of the system for multiple procedures. The Senhance Ultrasonic System functions similarly to other ultrasonic devices by creating high frequency vibration that denatures proteins, causing hemostasis. Ultrasonic energy has the advantage of minimizing thermal spread during dissection.
The Senhance Ultrasonic System has been deemed substantially equivalent to a predicate device (the Harmonic scalpel).
The Senhance Surgical System is approved for use in minimally invasive gynecological surgery, colorectal surgery, cholecystectomy and inguinal hernia repair.
The use of this device is contraindicated for procedures not listed above. Also it should not be used if there is absolute contraindication to laparoscopic surgery.
