Gentherm Medical’s Hemotherm Model 400CE cardiovascular heater/cooler device now able to be utilized for treatment of COVID-19 patients under US Food and Drug Administration Emergency Use Authorization for ECMO Devices

Gentherm, a global market leader and developer of innovative thermal management technologies announced that via the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), the Company’s Hemotherm Model 400CE Dual Reservoir Cooler-Heater can be used to treat patients with COVID-19.

The Hemotherm Model 400CE Dual Reservoir Cooler-Heater delivers reliable, effective blood temperature management control during cardiopulmonary by-pass and other related cardiovascular procedures. In treating COVID-19 patients, the system controls the temperature of the water flowing through a blood oxygenator/heat exchanger that is used to cool or warm blood during long-term respiratory/cardiopulmonary support in an extracorporeal membrane oxygenator (ECMO) circuit.

“The use of the Emergency Use Authorization from the FDA opens the way for Gentherm to provide support to healthcare professionals in treating patients with severe symptoms of COVID-19,” said Phil Eyler, President and CEO of Gentherm. “Thanks to the enormous effort of our team we are able to meet the needs of patients, their families and healthcare workers with a greater sense of urgency and responsibility during this pandemic.”

The use in ECMO therapy is temporary where the EUA allows for the distribution and emergency use of Hemotherm Model 400CE Dual Reservoir Cooler-Heater only for the treatment of COVID-19.

Gentherm Medical’s Blanketrol III hyper-hypothermia system is also being used by hospitals across the United States and Europe to support patient temperature management needs during these unprecedented times.