Alesi Surgical Limited, a developer of minimally invasive surgery technologies, has secured U.S. Food and Drug Administration (FDA) approval for its Ultravision system.
 
The Ultravision system clears the vapor and particulate matter generated by modern surgical cutting instruments during abdominal keyhole (laparoscopic) surgery through the use of electrostatic technology. The technology dramatically and effortlessly improves visibility for surgeons that is otherwise rapidly obscured by this “plume” or “surgical smoke,” according to the company.
 
“We are thrilled to have gained FDA approval for our Ultravision system that will now allow us to enter the U.S. market. Commercially the U.S. represents approximately 50 percent of the global medical device market and so it is difficult to overstate the importance of this for the company,” said Dr Dominic Griffiths, managing director of Alesi Surgical.
 
Alesi Surgical becomes a member of a group of only 26 medical device companies worldwide in the last 12 months that have successfully navigated the FDA's De Novo regulatory review process.
 
The Ultravision system, which produces a small, low-energy electrostatic charge similar to the principal of static electricity, is able to greatly improve visibility for surgeons by actively getting rid of surgical ‘smoke’.
 
The technology also benefits the patient as it minimizes the amount of cold, dry carbon dioxide gas—used to create a working space inside the abdomen—which a patient is exposed to during the keyhole procedure. It is not uncommon for abdominal keyhole procedures to require several hundred litres of this gas to clear the visual field throughout the procedure. Excessive use of carbon dioxide contributes to post-surgical pain and prolongs recovery time for the patient.
 
FDA approval is a significant milestone on the road to the company gaining traction in a global market worth an estimated 800 million British pounds per year and forms part of the strategic growth of the business that has also seen the appointment of a United Kingdom-based national sales team.
 
“Gaining FDA approval for Ultravision allows us to continue the progress and development in the U.S. market. This is the next step after launching our new Ultravision Trocar product in Europe which integrates the benefits of Ultravision into a pen-like access device, used in over 7 million abdominal keyhole procedures performed annually, worldwide," Griffiths said. "The combination of these two major achievements places us in a strong position to enter 2017 with confidence.”
 
Alesi Surgical launched in 2009 as a spin out from the internationally recognized Welsh Institute of Minimally Invasive Surgery, part of Cardiff University. To date, Alesi has secured 6.1 million pounds' worth of venture capital funding, principally from its lead investors IP Group PLC and Finance Wales Limited.
 
“We are delighted with the progress Alesi is making and gaining this FDA clearance provides a cornerstone for their future success. We are pleased to support Alesi as they enter the U.S. market and look forward to further growth of this innovative Welsh company,” said Phil Barnes of Finance Wales.
 
Alesi Surgical develops and commercializes products that improve the safety, efficiency and outcomes of advanced surgical procedures. The company was founded in 2009 as a spin-out from the Welsh Institute for Minimal Access Therapy (WIMAT), with the vision of becoming a world leader in surgical devices. Part of Cardiff University, WIMAT runs multi-disciplinary training courses across a range of surgical and medical specialties and is the busiest multi-disciplinary training centre in the United Kingdom.