COLLEGE STATION, Texas, March 26, 2020 /PRNewswire/ — CardioQuipTM, LLC, a medical device manufacturer focused on development and commercialization of patient temperature control and cardiovascular perfusion technology announced today it has received CE Mark approval for the MCH-1000TM Modular Cooler-Heater SeriesTM. The MCH-1000 Series of cooler-heaters is now available to European hospital systems fighting the COVID-19 pandemic.
A cooler-heater device is used to regulate patient temperature in many types of medical procedures, especially those involving the heart and lungs. Most notably, the MCH-1000 can potentially be used to treat acute respiratory distress syndrome (ARDS) associated with COVID-19 through a treatment called Extracorporeal Membrane Oxygenation (ECMO)1. ECMO provides increased systemic oxygen delivery and mitigates ventilator-induced lung injury.
“Landing the CE Mark is a tremendous milestone for CardioQuip,” said Doug Platt, CEO. “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 CE Mark confirms that the MCH-1000 meets the Essential Requirements of the Medical Device Directive (93/42/EEC). CardioQuip also received ISO 134385:2016 certification of its quality management system following completion of an audit by BSI, an EU Notified Body. The MCH-1000 received FDA 510(k) clearance in the United States in 2011.
Numerous patient deaths linked to non-tuberculosis mycobacterium (NTM) growth in European manufactured cooler-heaters have highlighted the need for safety and water quality in cooler-heaters. The safety of the MCH-1000’s open tank design paired with its simplified cleaning protocol and ease of use have made it the best-selling cooler-heater in the U.S. Market.
“We are excited to be in the final stages of agreements with European distribution partners to aide our commercialization efforts and get the MCH-1000 to the EU as quickly as possible,” added Platt.
1MacLaren G, Fisher D, Brodie D. Preparing for the Most Critically Ill Patients With COVID-19: The Potential Role of Extracorporeal Membrane Oxygenation. JAMA. Published online February 19, 2020. doi:10.1001/jama.2020.2342
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SOURCE CardioQuip, LLC