CardioQuip has received CE Mark approval for the MCH-1000 Modular Cooler-Heater Series, which is now available to the European healthcare systems dealing with the coronavirus (Covid-19) pandemic.
The MCH-1000 can be used to regulate patient temperature during different medical procedures, especially those involving the heart and lungs.
The bright TFT colour LCD of the MCH Series provides up-to-the-second information and quick temperature response.
CardioQuip said that the device can potentially be used for Extracorporeal Membrane Oxygenation (ECMO), a treatment for acute respiratory distress syndrome (ARDS) associated with Covid-19.
ECMO is said to enable increased systemic oxygen delivery and mitigates ventilator-induced lung injury.
CardioQuip CEO Doug Platt said: “Landing the CE Mark is a tremendous milestone for CardioQuip. The approval allows us to offer our technology to major hospitals all over the European Union (EU) at a time when it is greatly needed.”
The company noted that patient deaths linked to non-tuberculosis mycobacterium (NTM) growth in cooler-heaters manufactured in Europe have highlighted the need for safety and water quality in cooler-heaters.
To ensure safety, MCH-1000 features an open-tank design paired with its simplified cleaning protocol and ease of use.
Platt added: “We are excited to be in the final stages of agreements with European distribution partners to aide our commercialisation efforts and get the MCH-1000 to the EU as quickly as possible.”
CardioQuip also received ISO 134385:2016 certification of its quality management system, following the completion of an audit by the EU Notified Body, BSI.
The MCH-1000 received FDA 510(k) clearance in the US in 2011.