FDA clears Palliare device to get smoke out of operating room

Palliare announced today that it received FDA 510(k) clearance for its EVA15 insufflator and smoke evacuation system for operating rooms.

Galway, Ireland-based Palliare’s EVA15 is designed to meet insufflation requirements in endoscopic and robotic surgery while offering integrated surgical smoke evacuation capability, according to a news release.

The insufflator filters hazardous smoke particles produced during laparoscopic surgery and removes them from the operating room, allowing a reduction in device footprint by 50% and potentially reducing the cost of procedures. Through pedal-activated smoke evacuation and OR scavenging system connection capabilities, smoke is completely removed from the OR and not recirculated, the company said.

“EVA15 is the optimal solution for insufflation and surgical smoke evacuation, with one device managing two of the most critical needs for these types of surgical procedures,” Palliare managing director Caroline O’D…

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