Advanced temperature control technology to help European hospitals fighting COVID-19 outbreak
COLLEGE STATION, Texas, March 26, 2020 /PRNewswire/ -- CardioQuip(TM), LLC, [https://c212.net/c/link/?t=0&l=en&o=2761899-1&h=393055902&u=https%3A%2F%2Fwww.cardioquip.com%2F&a=CardioQuipTM%2C+LLC%2C] 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-1000(TM) Modular Cooler-Heater Series(TM) [https://c212.net/c/link/?t=0&l=en&o=2761899-1&h=3467274068&u=https%3A%2F%2Fwww.cardioquip.com%2Fmch&a=MCH-1000TM%C2%A0Modular+Cooler-Heater+SeriesTM]. The MCH-1000 Series of cooler-heaters is now available to European hospital systems fighting the COVID-19 pandemic.
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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.
For more information on the MCH-1000(TM) and CardioQuip, follow us on Twitter @CardioQuip [https://c212.net/c/link/?t=0&l=en&o=2761899-1&h=1620337459&u=http%3A%2F%2Fwww.twitter.com%2Fcardioquip&a=%40CardioQuip] and LinkedIn [https://c212.net/c/link/?t=0&l=en&o=2761899-1&h=1741123868&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fcardioquip&a=LinkedIn] or visit https://www.cardioquip.com [https://c212.net/c/link/?t=0&l=en&o=2761899-1&h=2989050935&u=https%3A%2F%2Fwww.cardioquip.com%2F&a=https%3A%2F%2Fwww.cardioquip.com].
(1)MacLaren 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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Web site: https://www.cardioquip.com/