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’Dea said in the release. “We are excited to receive FDA 510(k) clearance for EVA15, marking a crucial step toward bringing this important product to market later this year.”
Additionally, Palliare announced that it appointed former Invuity (purchased by Stryker) CEO Scott Flora as chairman of its board, while Irish medtech entrepreneur John O’Shaughnessy also received a position on the board of directors.
“We are delighted to have Scott Flora and John O’Shaughnessy join the Palliare Board,” O’Dea said. “Palliare will greatly benefit from their significant experience as we prepare for the EVA15 product launch.”
Original Article: (https://www.massdevice.com/fda-clears-palliare-device-to-get-smoke-out-of-operating-room/)
