Alesi Surgical pioneering surgical device gains United States FDA approval
Alesi Surgical Limited, the leading innovator of minimally
invasive surgery technologies has successfully secured FDA (Food
and Drug Administration) approval for its Ultravision™ system.
The Ultravision™ system is a world first that clears the vapour
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”.
“We are thrilled to have gained FDA approval for our
Ultravision™ system that will now allow us to enter the US market.
Commercially the US represents approximately fifty per cent 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 select group of only 26
medical device companies worldwide in the last 12 months that have
successfully navigated the FDA De Novo regulatory review
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 minimises 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
£800m per year and forms part of the strategic growth of the
business that has also seen the appointment of a UK national sales
Dr Griffiths said: “Gaining FDA approval for Ultravision™ allows
us to continue the progress and development in the US 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 seven million abdominal
keyhole procedures performed annually, worldwide. 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 recognised Welsh Institute of Minimally Invasive
Surgery, part of Cardiff University. To date, Alesi has
secured £6.1m worth of venture capital funding, principally from
its lead investors IP Group PLC and Finance Wales Limited.
Phil Barnes of Finance Wales said, “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 US market and look forward to further
growth of this innovative Welsh company.”