TransEnterix files FDA 510 (k) for Senhance Ultrasonic Instrument System
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TransEnterix Inc., a medical device company that provides a digitized interface between surgeons and patients, filed a FDA 510(k) submission for its Senhance Ultrasonic Instrument System to improve minimally invasive surgery that could help increase patient safety.
Advanced energy devices, including ultrasonic devices, are some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to ligate and divide tissue, and minimize thermal injury to surrounding structures.
Surgeons can operate the instruments in digital laparoscopic surgeries, where they use a digitized interface to make small incisions in the abdomen or pelvis of a patient with the aid of a camera.
TransEnterix CEO, Todd M. Pope says, “Advanced energy devices are an important tool within laparoscopic surgery because of their applicability within a wide range of procedures.”
Dr. Guy Orangio, FACS, FASCRS, Chief Section of Colorectal Surgery at LSU Health New Orleans, and Past President of the American Society of Colon and Rectal Surgeons says, “Adding such capability to a digital laparoscopic platform will further enable wide clinical use.”
