Xenios said yesterday that it won CE Mark approval in the European Union for its I-Cor synchronized cardiac assist device, touting it as the world’s 1st “heartbeat-synchronized” cardiac assist for cardiogenic shock and high-risk interventions.
Heilbronn, Germany-based Xenios, which claimed in September to have drummed up an 8-figure funding round, said the I-Cor system is designed to provide “beat-to-beat” cardiac assistance using a miniature pump “with synchronized pulses that are superimposed over the patient’s weakened heartbeats.”
“European regulatory approval of the I-Cor synchronized cardiac assist system now makes possible a whole new era for percutaneous cardiac assist,” managing director Dr. Georg Matheis said in prepared remarks. “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.”
“Patients with cardiogenic shock have a very high mortality rate,” added managing director Dr. Juergen Boehm. “In fact, cardiogenic shock as the result of a heart attack is a medical emergency, resulting from an inadequate circulation of blood due to primary failure of the heart ventricles to function effectively. As this is a type of circulatory shock, there is insufficient perfusion of tissue to meet the demands for oxygen. The condition involves increasingly more pervasive cell death from oxygen starvation (hypoxia). We are pleased that interventionists will now have a powerful new treatment with which to reduce morbidity and mortality from cardiogenic shock or high-risk interventions.”