U.S. FDA Grants 510(k) expanded indication for Palliare’s EVA15 insufflation technology to accommodate higher pressure range
Palliare, a leading developer of advanced insufflation technologies, has received an expanded 510(k) indication from the U.S. Food and Drug Administration for its EVA15 Insufflator to provide an extended pressure delivery range of up to 25mmHg. This increased pressure range represents the highest-performing robotic insufflator on the market to offer continuous pressure insufflation, with integrated smoke evacuation, and is designed for surgical, laparoscopic, and robotic surgeries. In addition to the extended pressure range, the updated EVA15 insufflator will for the first time offer two levels of insufflation pressure that can be alternatively selected in a hands-free manner by endoscopic surgeons, which is particularly useful when performing emerging endoscopic procedures such as endobariatric, or GERD, surgeries.
John O’Dea, CEO of PalliareWe believe EVA15 represents the highest-performing, most flexible insufflation platform on the U.S. market, with a compact size enabling its easy integration in emerging endo-luminal and robotic surgery platforms. The company continues to develop a strong intellectual property portfolio, and we are pleased to have recently received U.S. and E.U. patents for energy-activated smoke evacuation in continuous pressure (robotic) insufflators. This means that smoke evacuation is activated only when energy is being used for tissue dissection and does not introduce CO2 needlessly to the patient when not required.
Dr. Silvana Perretta, Professor of Surgery at the University of Strasbourg, France, Vice President of IRCAD, and Chairperson of Palliare’s Medical Advisory Board, said, “Higher insufflation pressures can be particularly useful with very high BMI patients undergoing bariatric surgery, and in certain instances to control bleeding during liver surgery. The new physician-activated bilevel pressure modality (PABI) starts to address what has been a deficit of workable insufflation solutions for emerging endoscopic surgery procedures such as endoscopic sleeve gastroplasty (ESG). EVA15 takes flexible endoscopy insufflation into this century and fills a major gap in interventional endoscopy, making it safer and pressure-controlled, opening the door to real transluminal flexible surgery.”
The EVA15 insufflator and smoke evacuation system is the first in a line of products from Palliare designed to deliver best-in-class insufflation and smoke evacuation performance to meet the particular demands of laparoscopic, endoluminal, endoscopic, and robotic surgical procedures. EVA15 maintains continuous 7-25mmHg pressure and automatically compensates for leaks and suctioning. The insufflator instantaneously sees a pressure drop and adds extra flow, regardless of why there is flow out of the cavity. It maintains the surgical field during tool/camera removal and smoke evacuation.
About Palliare
Palliare is a privately funded company founded in 2018 as a spinout from gastro-diagnostic company Crospon, which was acquired by Medtronic (NYSE:MDT) in 2017. Based in Galway, Ireland, with U.S. headquarters in Oceanside, CA, Palliare’s vision is to become the world technology leader in advanced insufflation by innovating to meet the needs of minimally invasive procedures. The company’s state-of-the-art evacuation and insufflation technologies are appropriate for laparoscopic, endoluminal, endoscopic, colorectal, and robotic surgeries.
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Vicky La Touche-Price
Further information about Palliare