German medical technology firm Xenios has received CE Mark for its i-cor synchronised cardiac assist system for sale in Europe.
i-cor, which is claimed to be the world’s first heartbeat-synchronised cardiac assist for cardiogenic shock and high-risk interventions, uses a miniaturised pump to provide physiological beat-to-beat cardiac assistance.
The system is designed to combine myocardial protection with organ perfusion by assisting the weakened heart with synchronised pulses that are superimposed over the patient’s weakened heartbeats.
The company noted the new system will improve coronary blood flow and limit afterload compared to conventional methods.
Xenios managing director Dr Georg Matheis said: "European regulatory approval of the i-cor synchronised cardiac assist system now makes possible a whole new era for percutaneous cardiac assist.
"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 synchronised cardiac assist, unlike continuous-flow percutaneous systems, the i-cor system is the world’s first to synchronise mechanical circulatory support with the patient’s weakened heartbeat.
"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."
Synchronised cardiac assist overlays or superimposes a physiological pulse wave onto the patient’s weakened pulse and is designed to be a less invasive treatment than the current standard.
It uses a more physiological treatment needed for endothelial function, which ensures adequate tissue perfusion in the organs.
The oxygenating power of the i-cor system reduces invasiveness compared to standard care by reducing blood flow and cannula size.
The company has two product brands, Novalung and i-cor, which run on a single Xenios platform. Novalung offers the full spectrum of extrapulmonary lung support, while i-cor focuses on heart therapies.