CE mark for Xenios® i-cor® Synchronized Cardiac Assist System

The i-cor® Synchronized Cardiac Assist System from XENIOS® has received CE marking, making it Europe’s first-to-market heartbeat-synchronized cardiac assist device for cardiogenic shock and high-risk interventions.

Background

XENIOS says its platform, comprising novalung® and i–cor® is designed for physicians to treat the same patient who either has certain singular lung or heart issues, or has concomitant lung and heart issues. It’s effectively one platform of minimally invasive products that do not require mechanical ventilation, sedation, and immobility.

The i-cor Synchronized Cardiac Assist system “overlays”  a physiological pulse wave onto the patient’s weakened pulse and is designed to be a less invasive treatment than the current standard while using a more physiological treatment essential to endothelial function, which ensures adequate tissue perfusion in the organs.

This is intended to help maintain organ function, thereby preventing multi-organ failure. The oxygenating power of the i-cor Synchronized Cardiac System claims to allow for a reduction of invasiveness compared to standard care by reducing blood flow and thus reducing cannula size. As a result, i-cor is 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 Synchronized Cardiac Assist System uses a miniaturized pump to provide physiological beat-to-beat cardiac assist. With this ECG-triggered heartbeat i-cor is designed to significantly improve coronary blood flow and limit afterload compared with conventional methods.

Company comments

“European regulatory approval of the i-cor Synchronized Cardiac Assist System now makes possible a whole new era for percutaneous cardiac assist,” said Georg Matheis, MD, Managing Director of XENIOS. “We are able to superimpose or overlay an artificial heartbeat over each weakened heartbeat. Previously, there has been no such direct cardiac-assist modality.

“Now, with synchronized cardiac assist, unlike continuous-flow percutaneous systems, the i-cor system is the world’s first to synchronize mechanical circulatory support with the patient’s weakened heartbeat,” added Dr. Matheis. “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,” said Juergen Boehm, MD, Managing Director of XENIOS. “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.”

Source: Business Wire

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