Palliare has received EU CE mark approval for its EVA15 insufflator and smoke evacuation system. Credit: Palliare / Business Wire.

Palliare has secured EU CE Mark approval for its EVA15 insufflator and smoke evacuation system.

The approval has been granted in line with the new EU Medical Devices Regulation (MDR).

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Furthermore, the approval of EVA15 establishes it as one of the first laparoscopic and endoscopic insufflators to meet Europe’s more extensive 2021 regulatory requirements for medical devices.

The new system is intended for creating a safer operating room environment while delivering better insufflation and smoke evacuation performance to meet the specific requirements of robotic, endoscopic, endoluminal and laparoscopic procedures.

Designed to deliver similar smoke evacuation and insufflation performance as ConMed’s Airseal system, the EVA15 system also secured approval from the US Food and Drug Administration.

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Palliare CEO John O’Dea said: “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.

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“We have now started the process of installing EVA15 in leading robotic surgical training centres in Europe.”

Palliare has also reached a group purchasing organisation agreement with New York-based Northwell Health.

Palliare worked with Northwell’s global strategic partnerships team and participated in their international business programme, an initiative designed for international companies to collaborate with the Northwell system.

Palliare was established in 2018 as a spinout from Irish gastro-diagnostic company Crospon, which was taken over by Medtronic in 2017.