Palliare designs and manufactures a range of device for the operating theatre and endoscopy suite. Its first product to market is its EVA15 continuous pressure insufflation and smoke evacuation system. The system is one of only two on the market offering this dual functionality in a single system. A further enhancement to the EVA15 system, utilising the new END-200 tubeset, permits continuous pressure insufflation during therapeutic endoscopic procedures, maintaining a working field despite the presence of large leaks. The company has recently received funding from the European Commission to develop a range of products, LeakTrap and EndoTrap, to reduce the risk of transmission of aerosolized virus to operating room and endoscopy suite staff. Clinical evaluations are commencing in August on these products.
EVA15 Continuous Pressure Insufflator for use during laparoscopic endolumenal and robotic surgery
LAP 300 continuous pressure laparoscopic tubeset
END 200 endoscopic insufflation tubeset
EndoTrap endoscopist protection device
LeakTrap OR protection device
Continuous pressure insufflators are designed to manage surgery in the presence of large leaks e.g. as typically found in robotic surgery, or during deliberate manoeuvres such as suctioning or smoke evacuation. They stop the surgical field from periodically collapsing, permitting the surgeon to continue to operate. Smoke is generated when energy devices are used to cut tissue during surgery. This needs to be removed to allow the surgeon see what they are doing. This is achieved by using a smoke evacuator. However most insufflators do not tolerate the suction of gas from the surgical cavity during smoke evacuation, with the result that the surgical working cavity collapses. EVA15 combines both a continuous pressure insufflator as well as a smoke evacuator in one compact system. It is one of only two systems on the market to combine both these features. The END-200 tubeset accessory, when used with EVA15, affords the same benefits to gastroenterologists performing therapeutic endoscopy procedures. It is the first system of its kind in the world, and gives endoscopists the same powerful insufflation features that have been available to laparoscopic surgeons for many years.
EVA15 and END200 tubeset are 510k cleared by US FDA. Certifcation to EU MDR is underway.