Alesi Surgical announces FDA clearance for groundbreaking Ultravision2 smoke management solution

?

The breakthrough new Ultravision system includes the world’s first surgical tool that integrates electrosurgery and class-leading surgical smoke control in a single laparoscopic device, providing expanded applications and access to larger markets.

?

Cardiff, United Kingdom Nov 28, 2023

?

Alesi Surgical, a leader in the development of advanced surgical aerosol control technologies, is excited to announce that the FDA in the United States has granted regulatory clearance for two ground-breaking new products.

?Dominic Griffiths, CEO of Alesi Surgical, commented “The first-generation Ultravision system established the Ultravision technology as a class-leading solution for managing surgical smoke during laparoscopic surgery. This is the next generation.? Healthcare practitioners asked for synchronisation and optimisation of the Ultravision energy, and integration of the technology into a surgical tool. Our response, through our own R&D team, was to develop and deliver the new Ultravision2 system and Laparoscopic L Hook. The L Hook, the most widely used surgical instrument in laparoscopy and integration of Ultravision, provides a totally unique solution to the level of surgical smoke it produces.? This integrated approach offers all the benefits of the Ultravision technology in a plug-and-play format, with no learning curve and no workflow changes. The functionality of this new generator creates future opportunities in open and robotic surgery that will deliver access to this disruptive technology to surgeons worldwide. Through this new technology platform we have the opportunity to disrupt large and growing global surgical markets worth an estimated $12bn annually. We look forward to delivering further solutions to the market in 2024.”

?

Alesi’s Ultravision technology is a revolutionary means of handling aerosols – often called “surgical smoke” –created during surgery by modern, energy-based surgical tools.? Instead of using mechanical filtration, the Ultravision technology utilises electrostatic precipitation, an electrical filtration process that is widely used in other industries to remove fine aerosols from waste gases that, uniquely in surgery, requires no gas exchange.? The Ultravision technology offers four benefits to its users and patients during laparoscopic procedures: advanced visualization, class-leading bioaerosol control, stable pneumoperitoneum pressure in both standard- and low-pressure surgery, and reduced workflow interruptions to help improve procedural efficiency.?

?

The “Ultravision2 System” cleared by FDA is the next-generation generator developed by Alesi that synchronises and optimises the application of the Ultravision energy in use –resulting in improved performance, consistency, and usability.?? It also paves the way for the development and launch of “integrated Ultravision instruments”, surgical tools that both perform tissue dissection and incorporate the class-leading surgical smoke handling performance offered by the Ultravision technology.? The first product is the Ultravision Laparoscopic L Hook, the most commonly-used surgical instrument for the circa 10m laparoscopic surgery procedures performed each year, globally.

?

ABOUT ULTRAVISION TECHNOLOGY

The Ultravision technology is the only solution that addresses surgical smoke at the source, without the need for gas exchange or filtration.? Independent data demonstrates that the Ultravision technology is best-in-class for:

?

-?????? Minimising the production and subsequent escape of potentially hazardous surgical smoke into the operating room where it would otherwise be inhaled by OR personnel.? In simulated surgery studies, Ultravision is 23x better than alternative systems in minimising smoke release into the operating room[i].? It also outperforms filtration-based systems by being effective to 7nm particle size, which is 15 times smaller than the specified performance rating of filtration-based systems incorporating a ULPA filter[ii]. 7nm is approximately 1/10th the size of a virus particle. Recently published has demonstrated that in simulated studies Ultravision is capable of capturing and reducing the infectivity of non-enveloped and enveloped viruses such as SARS-CoV-2[iii].

-?????? Maintaining high-quality visualisation of the operative site throughout a surgical procedure. Ultravision suppresses the aerosolization of the smoke as it is created, such that 46-225 times less smoke is generated, depending upon the instrument and surgical procedure[iv].? What remains is rapidly eliminated from the atmosphere compared to competing devices, which rely on the slow and inefficient process of gas removal, mechanical filtration, and exchange.

-?????? Providing stable pneumoperitoneum in low- and standard pressure surgery, whilst minimising patient exposure to dry, cold, acidic carbon dioxide (CO2). ?Excessive CO2 exposure during laparoscopic surgery is associated with increased post-surgical pain, increased analgesia requirements, prolonged patient recovery times, and increased time to discharge from the hospital.? Excessive CO2 exposure also contributes to the formation of post-surgical adhesions, a band of scar tissue that joins two internal body surfaces that are not usually connected, which may result in the need for a further surgical procedure should the adhesion obstruct critical abdominal structures or organs. Ultravision is the only technology that can provide stable pneumoperitoneum whilst minimising the pressure, flow, and total volume of CO2 that a patient is exposed to[v].?

-?????? Maximising the efficiency of surgical procedures by minimising workflow interruptions that would otherwise prolong the duration of the procedure. Obvious workflow benefits include minimal camera cleaning, and fewer pauses caused by managing the smoke and loss of pneumoperitoneum[vi].

For further information, please visit alesi-surgical.com

?

References

[i] Buggisch JR et al (2020) J Am Coll Surg, Dec;231(6):704-712

[ii] Alesi internal report DREP-002, performed by Cardiff University.

[iii] Preston HE et al (2023)? iScience?Aug 9;26(9):107567

[iv] G?hler D et al, Journal of Aerosol Science (accepted)

[v] Levine D et al, (2020) JSLS, Oct-Dec;24(4):e2020.00051

[vi] Ansell J et al (2014) Surg Endoscopy, Jul;28(7):2057-65