Study data will be used for CE mark registration and FDA submission
Hemovent GmbH has announced that it has commenced a Good Laboratory Practice (GLP) in vivo study for the long-term (7 days) use of its novel and portable artificial lung technology platform, designed for a range of indications from ExtraCorporeal CO2 Removal (ECCO2R) to ExtraCorporeal Life Support (ECLS).
Both technologies refer to as ExtraCorporeal Membrane Oxygenation (ECMO) and enable the establishment of an artificial external blood circuit with a portable pump and gas exchanger system. This serves to support the lung function or to establish a full cardiopulmonary bypass. ECMO as a temporary ‘artificial lung’ either provides respiratory support to patients whose lungs are so damaged that they cannot perform their function, or as a temporary “life support system” in order to take over the heart function in case of an acute heart failure.
Subsequently, the data will be used for CE mark registration as well as for FDA status submission.