Palliare announces US FDA 510(k) clearance to extend the indications of its EVA15 insufflation technology for use in endoscopic surgery
Palliare, an emerging company with the vision to create a safer operating room, today announced that it has received FDA 510(k) clearance for its END-200 tubeset, which extends the capabilities of its EVA15 continuous pressure insufflation technology from laparoscopic surgery to endoscopic and endoluminal surgery.
- Palliare, an emerging company with the vision to create a safer operating room, today announced that it has received FDA 510(k) clearance for its END-200 tubeset, which extends the capabilities of its EVA15 continuous pressure insufflation technology from laparoscopic surgery to endoscopic and endoluminal surgery.
- 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.
- For complex, long or high leak therapeutic endoscopy procedures, current insufflation requires careful ongoing management by the endoscopist.
- Palliare was founded in 2018 as a spinout from Irish gastro-diagnostic company Crospon, which was acquired by Medtronic (NYSE:MDT) in 2017.