German startup gets CE mark for first cardiac assist system to work with an existing heartbeat

i-cor Synchronized Cardiac Assist System--Courtesy of Xenios

Startup Xenios has zeroed in on its platform of minimally invasive products to treat patients with heart and lung problems. Its latest addition is i-cor, a synchronized cardiac assist system that just received a CE Mark for marketing in Europe. This makes it the first heartbeat-synchronized cardiac assist device for cardiogenic shock and high-risk interventions.

The i-cor system is designed to offer a less invasive option than the current standard care that relies upon reducing coronary blood flow, which also reduces the size of the tube that can be inserted. It's intended to prevent multi-organ failure and improve clinical outcomes by offering physiological circulatory protection and support during cardiac catheterization lab intervention procedures, as well as for management of cardiogenic shock in the intensive care unit.

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

He added, "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. 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."

The i-cor system consists of a miniaturized pump that's triggered by an ECG; it is designed to significantly improve coronary blood flow and limit afterload as compared with conventional methods. It superimposes a physiological pulse wave onto the patient's weakened pulse. This is expected to help ensure adequate blood flow to bodily organs.

The Heilbronn, Germany-based startup also has novalung, a product designed for extra-pulmonary lung support. Both i-cor and novalung are designed to run on a single platform, as well as to be used in conjunction to treat patients with either or both heart and lung issues. The entire minimally invasive heart-lung Xenios system does not require mechanical ventilation, sedation or immobility.

In September, Xenios won a double-digit millions financing that was led by early stage German venture capital firm ZFHN. The cash infusion was slated to help the startup commercialize this lung-heart system that's united on a single console for use separately or together in the U.S. and Europe. However, the i-cor system isn't yet FDA-cleared; novalung gained FDA clearance in 2012.

"Patients with cardiogenic shock have a very high mortality rate. 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," said Xenios Managing Director Dr. Juergen Boehm. "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."

- here is the announcement

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