i-cor synchronised cardiac assist system recieves CE mark

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The i-cor synchronised cardiac assist system has been granted CE mark. According to a press release from Xenios AG, the product can now be sold in Europe as the world’s first heartbeat-synchronised cardiac assist for cardiogenic shock and high-risk interventions.

The i-cor system uses a miniaturised pump to provide physiological beat-to-beat cardiac assist. It is designed to combine myocardial protection with organ perfusion by assisting the weakened heart with synchronized pulses that are superimposed over the patient’s weakened heartbeats. With this ECG-triggered heartbeat, i-cor is designed to significantly improve coronary blood flow and limit afterload compared with conventional methods.

Georg Matheis, managing director of Xenios, says, “We are able to superimpose or overlay an artificial heartbeat over each weakened heartbeat. Previously, there has been no such direct cardiac-assist modality. This advance not only makes possible new therapy options for patients who are suffering from cardiogenic shock, but also is designed to bridge patients across high-risk interventions in the cardiac cath lab.”

According to the press release, the oxygenating power of the i-cor synchronised cardiac system allows for a reduction of invasiveness compared to standard care by reducing blood flow and thus reducing cannula size. i-cor is thus designed to offer physiological circulatory support, protection, and safety during interventions in the cardiac cath lab, as well as for the management of cardiogenic shock in the ICU and the cardiac cath lab.

The i-cor cardiac assist device from Xenios is not cleared for sale in the United States.

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