The company received FDA clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the United States. With this clearance, Senhance System's total addressable annual procedures in the United States has more than doubled to over 3 million.
“This indication expansion immediately doubles the addressable market for Senhance in the U.S. and validates our regulatory strategy to successfully add to our indications for use,” said Todd M. Pope, president and CEO of TransEnterix. “These expanded procedures are commonly performed at over 95 percent of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice.”
In the United States, Senhance is now cleared for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery. This enables Senhance to be used for some of the most common abdominal surgeries, including procedures in general surgery and gynecology.
“We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery and colorectal procedures at our institution,” said Professor Dr. Frank Willeke, chief of surgery at St. Marien Hospital in Siegen, Germany. “We believe this procedural expansion for the U.S. will allow surgeons there to incorporate the Senhance, as we have, as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties.”
TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today's value-based healthcare environment. The company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the United States, the European Union, and select other countries.