CE Mark Awarded to Palliare’s EVA15 Insufflator and Smoke Evacuation System

Palliare has gained EU CE Mark certification under the new EU Medical Devices Regulation (MDR) for its EVA15 insufflator and smoke evacuation system. This makes it one of the first laparoscopic and endoscopic insufflators to meet the new more extensive regulatory requirements introduced in 2021 for medical devices in Europe and allows the company to begin shipments to the European market.
 
“We believe that this is an important step forward for our company. Certifying EVA15 as a Class 2b device to the new MDR regulation has entailed an extensive exercise, one that puts the company on a firm regulatory approval footing in Europe for the coming years,” Palliare CEO John O’Dea said. “We have now started the process of installing EVA15 in robotic surgical training centers in Europe.”

The EVA15 insufflator and smoke evacuation system is the first product from Palliare, designed to create a safer operating room environment and deliver best-in-class insufflation and smoke evacuation performance to meet the particular demands of laparoscopic, endoluminal, endoscopic, and robotic surgical procedures. EVA15 is cleared for sale by the U.S. Food and Drug Administration and offers similar smoke evacuation and insufflation performance to the Conmed Airseal system.
 
“Certification is a key pillar for companies in the medical devices sector to drive innovation, ensure quality, and to gain market accessibility,” NSAI CEO Geraldine Larkin stated. “Ireland is a major hub for the medical devices sector in Europe and the ability of the NSAI to certify products for access to the European market is an important part of our work in supporting Irish business.”
 
Palliare has signed its first U.S. GPO agreement—with Northwell Health, New York’s largest healthcare provider. Palliare engaged with Northwell’s Global Strategic Partnerships team and went through its International Business Program, an initiative that enables international companies to work with the Northwell system. Elaine Brennan, executive director of Global Strategic Partnerships, said, “We created this program to streamline engagement with international companies that add value for Northwell—from procurement to pilots to investment opportunities—and we’re glad to add Palliare as a solution for Northwell and partner within the GPO alliance.”
 
“Palliare’s smoke evacuation and insufflation technologies are transforming surgical operating rooms, addressing the growing demands of patient procedures while also enhancing safety. Enterprise Ireland proudly supports Palliare’s U.S. scaling journey, and are delighted that Palliare and Northwell Health, a strategic partner of Enterprise Ireland, have collaborated to accelerate the adoption of these transformative technologies, driving improved patient outcomes,” added David Corcoran, head of U.S. LifeSciences for Enterprise Ireland.
 
Palliare was founded in 2018 as a spinout from Irish gastro-diagnostic company Crospon, which was acquired by Medtronic in 2017. Based in Galway, Ireland, and with U.S. headquarters in Oceanside, Calif., Palliare aims to advance smoke evacuation and insufflation technologies for laparoscopic, endoluminal, endoscopic, and robotic surgery.