Palliare announces US FDA 510(k) clearance to extend the indications of its EVA15 insufflation technology for use in endoscopic surgery
Shipments of new END-200 tubeset to commence in Q4-2021
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Example of a hybrid laparo-endoscopc surgical procedure using Palliare's EVA15 insufflator pltform (Photo: Business Wire)
Commenting on the clearance, John O’Dea, CEO, said “We believe that this is an important step forward in the evolution of insufflation technology, one expressly and uniquely purposed for endoluminal surgery of the gastrointestinal tract. EVA15 is the first insufflator of its kind to be brought to market which will allow intelligent leak-tolerant constant pressure insufflation during endoscopic surgery, features that EVA15 currently offers for laparoscopic and robotic surgery. As new instruments and surgical robots emerge for natural orifice endoluminal surgery, new demands are placed on insufflators to reliably maintain the surgical field in the presence of large leaks. We believe that the EVA15 with END-200 tubeset is uniquely positioned to address these demands”. Shipments of the END-200 are expected to commence in Q4-2021.
About the EVA15 Insufflator
The EVA15 insufflator and smoke evacuation system is the first product from Palliare, designed to create a safer operating room environment and deliver best-in-class insufflation and smoke evacuation performance to meet the particular demands of laparoscopic, endoluminal, endoscopic, and robotic surgical procedures.
Palliare was founded in 2018 as a spinout from Irish gastro-diagnostic company
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