TransEnterix Announces CE Mark Approval for Pediatric Indication for Senhance Surgical System
“Given the size of the patients, pediatric surgery seeks to use the smallest instruments and scopes possible to minimize invasiveness, yet it is critical to maintain a high degree of precision,” said
“The ability to use 3 mm microlaparoscopic instruments on a robotic platform is very exciting and is a large step forward in treating pediatric patients,” said Prof. Dr.
The Senhance® Surgical System is the first and only digital laparoscopic platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, eye-sensing camera control, comfortable ergonomics, advanced instrumentation including, 3 mm microlaparoscopic instruments, eye-sensing camera control and reusable standard instruments to help maintaining per-procedure costs similar to traditional laparoscopy.
Senhance European Indication for Use
The Senhance® Surgical System has received a CE Mark according to the Medical Device Directive and is intended to be used for laparoscopic surgery in the abdomen, pelvis and limited uses in the thoracic cavity excluding the heart and greater vessels. The system is indicated for adult and pediatric use in CE marked territories.
This press release includes statements relating to the Senhance System and the expansion of indications to include pediatric applications in CE marked territories. These statements and other statements regarding our future plans and goals constitute "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including whether the indication expansion to treat pediatric patients will broaden our Senhance footprint in CE countries and whether the Senhance System technology is uniquely positioned to meet the requirement of pediatric surgeons. For a discussion of the risks and uncertainties associated with
Mark Klausner, +1 443-213-0501
Terri Clevenger, +1 203-682-8297