TransEnterix, a Morrisville medical device company that uses robotics to improve minimally invasive surgery, has expanded the clinical adoption of its Senhance Robotic Surgical System to include a full range of hernia repairs.
Senhance is a multi-port robotic system that allows multiple arms to control instruments and an eye-sensing camera with haptic feedback, or the sense of touch. The system simulates laparoscopic motion familiar to experienced surgeons and features three-dimensional, high-definition vision technology.
TransEnterix acquired Senhance, previously called ALF-X, in 2015 by purchasing the surgical robotics division of SOFAR S.p.A., an Italian health care company. The cash and stock deal totaled $99.8 million.
Senhance has been granted a CE Mark, a regulatory approval allowing its sale in countries within the European Economic Area for laparoscopic abdominal and pelvic surgery, as well as limited thoracic operations excluding cardiac and vascular surgery. The system is not currently available for sale in the United States, but the company is aiming for FDA approval in 2017.
Market exceeds 2 million hernia repairs in U.S. and Europe alone
Hernia repairs represent one of the largest procedural opportunities for the Senhance. Millennium Research Group has estimated that during 2017, there will be a total of 1,080,400 hernia repair surgeries in Europe and 1,156,300 hernia repair surgeries in the United States.
“Robotic hernia repair with the Senhance system represents a significant procedural area for our technology,” said Todd M. Pope, president and CEO of TransEnterix. “Hernia repairs, both inguinal and ventral, are amongst the most common surgical procedures performed worldwide. These procedures also represent one of the fastest growing uses of robotics in surgery. The introduction of Senhance to provide robotic assistance in these procedures brings a system with haptic feedback and attractive procedural costs to these operations for the first time.”
German hernia center launches Senhance
St. Marien-Krankenhaus Siegen in Germany, a major hernia repair center that performs over 500 hernia repairs annually, was the first site to begin using the Senhance for unilateral and bilateral inguinal hernia repairs as well as ventral hernia repairs. Dr. Dietmar Stephan and Prof. Dr. Frank Willeke performed up to three robotic hernia surgeries per day with the Senhance during the first weeks of its clinical use at the hospital. This allowed the team to adopt Senhance to include the day’s full operating schedule.
“We are pleased to offer robotic hernia repair utilizing the Senhance Robotic System, and all our operations utilizing this advanced technology have been performed with precision, safety and efficiency,” said Dr. Dietmar Stephan, director of the Center for Minimally Invasive Surgery at St. Marien.
“The 3D visualization and precise control of the robotic instruments and camera are very helpful during delicate surgical tasks. The haptic feedback of the system is vital, and it allows me to feel the location of critical structures, such as the pubic bone, which aren’t always visible. The Senhance is a significant progression in the field of minimally invasive hernia repair, and allows me to fully incorporate robotics into my hernia practice without having to justify high additional procedural costs.”
Company is a 2006 Duke spinout
TransEnterix, a Duke University spinout, is also developing the SurgiBot System, a single-port robotically enhanced laparoscopic surgical platform. SurgiBot is not approved for sale in any market. The FDA declined to approve it in April, ruling that TransEnterix had not shown it to be substantially equivalent to devices already on the market.
Both robotic systems are intended to give surgeons greater precision when operating with laparascopes, thin instruments with cameras that are inserted into the body through a small surgical incision. Smaller incisions generally result in less post-operative discomfort, quicker recovery times, shorter hospital stays, earlier return to full activities, smaller scars and less internal scarring when compared to standard open surgery.
TransEnterix was founded in 2006, and its shares are publicly traded on the New York Stock Exchange.
(C) N.C. Biotechnology Center
