The system is claimed to be the world’s first heartbeat-synchronized cardiac assist for cardiogenic shock and high-risk interventions. It uses a miniaturized pump to provide physiological beat-to-beat cardiac assist.

Xenios has developed i-cor to aggregate myocardial protection with organ perfusion, helping to provide weakened heart with synchronized pulses that are superimposed over the patient’s weakened heartbeats.

According to the company, the i-cor will improve coronary blood flow and limit afterload compared against conventional methods.

Xenios managing director Dr Georg Matheis said: "European regulatory approval of the i-cor Synchronized 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."

The company has two product brands, novalung and i-cor, which run on a single Xenios platform.

Novalung provides the full spectrum of extrapulmonary lung support, while the i-cor focuses on heart therapies.