FDA Clears 270Surgical’s Extended Field-of-View Laparoscopic System

270Surgical Ltd. announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its SurroundScope System, the first laparoscopic camera system to offer up to 270-degree field-of-view (FoV).
 
Despite significant advances in laparoscopic visualization, the issue of restricted FoV has gone unaddressed, as most laparoscopes used today typically have a 70 to 90-degree FoV. Looking back, FoV has been a challenge for laparoscopy that has been described in the literature since the early 1900s. It is the result of “tunnel vision”, which can impede efficiency and increase the likelihood of off-screen injuries. It may also limit the types of procedures that are performed laparoscopically. In 2017, it is estimated that 3.5 million laparoscopic procedures were performed in the U.S. across 12 procedure types according to iData Procedure Tracker.
 
The SurroundScope is the first marketable laparoscope that offers up to a 270-degree field of view, which is an increase of 200 percent compared to other laparoscopes in the market. The technology consists of a hardware, software and electro-optic solution that incorporates a myriad of lenses at the distal end of the scope.  The end result is a specialty laparoscopic system that solves this longest standing challenge in laparoscopy. The expanded field of view offered by the SurroundScope is expected to have considerable implications for procedures performed within the disciplines of general surgery, trauma, OBGYN, and thoracic surgery.
 
“We are excited to have received FDA clearance for our innovative laparoscopic system. We believe this will make a profound impact in laparoscopic surgery. In order to achieve this important milestone, our team pushed the technology envelope, including the integration of a myriad of lenses and LEDs at the distal end of the scope,” stated Avi Levy, CEO and founder of 270Surgical. “The feedback we’ve received from surgeons around the globe, including those that have used the SurroundScope system in human trials, has been overwhelmingly positive. We believe that such a strong response suggests that the impact of expanding image quantity may be the most significant advancement in laparoscopy in several decades.”
 
“We believe the benefits offered by the SurroundScope are significant and position it to be a disruptive new technology in the multi-billion-dollar laparoscopic visualization market. In addition, we believe that this technology may extend the reaches of laparoscopy,” stated Chad Croasdale, President and Chief Commercial Officer of 270Surgical. “We are actively preparing for the U.S. commercial launch of the SurroundScope in the second half of 2020.”