EVA15 Surgical Insufflator And Smoke Evacuator For Minimally Invasive Procedures FDA Cleared

Palliare, a company out of Galway, Ireland, won FDA clearance for its flagship product, the EVA15 insufflator and smoke evacuation system. The EVA15 combines two devices into a compact package that is designed for use in laparoscopic, endoscopic, endolumenal, and robotic procedures.

Smoke is a common problem in all kinds of minimally invasive procedures that involve ablation, cauterization, and other kinds of tissue manipulation. Smoke makes it difficult to see the surgical scene, but it can also be harmful to the clinicians that end up breathing in the soot. According to the American Association of periOperative Registered Nurses (AORN), a single day in the operating room may be equivalent to smoking more than a pack of cigarettes as far as mutagenicity goes.

Insufflation pumps CO2 into the surgical scene, thereby clearing it of the smoke and allowing clinicians to see clearly within. Evacuation is used to move the smoke away from the staff, hopefully straight into an OR scavenging system. The EVA15 also has a built-in 0.1 micron two-stage filter that helps to remove some of the dangerous particles within the smoke at an efficiency of 99.998%, according to Palliare. There’s also the option to install a second filter to clean the smoke even more.

The compact system is operated via a pedal, which helps to use CO2 only when necessary, lowering costs, and, because the gas is cold, preventing patients from freezing on the inside. There are three insufflation modes that the device can operate in, which are constant flow, standard insufflation, and continuous pressure insufflation. The last is able to compensate for any leaks so that the CO2 entering the surgical scene comes in at the appropriate pressure to keep things clear. There’s also the low-pressure insufflation option that keeps pressure at no more than 7mmHg. The operator simply presses the power button to turn on the device and then selects the mode to start operation.

“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,” said Caroline O’Dea, Managing Director, Palliare, in a press release. “We are excited to receive FDA 510K clearance for EVA15, marking a crucial step toward bringing this important product to market later this year.”

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