News | May 14, 2009

Cardiola Gets CE Mark Recertification for m.pulse System for CHF Patients

May 14, 2009 - Cardiola AG received CE mark recertification to market its m.pulse system for at-home use to treat chronic heart failure (CHF), the most frequent cause of hospitalization in persons 65 and older.
Current treatments for CHF, including drugs, implantable defibrillators/pumps and heart transplantation, have significant risks and side effects. Cardiola’s m.pulse system, based on muscular counterpulsation (MCP) technology, has been recertified in Europe for treating CHF as a nonsurgical, at-home therapy.

The battery-powered m.pulse, the size of a cell phone that the patient attaches to their belt for about 45 minutes per treatment, is synchronized to the patient's cardiac cycle to stimulate the muscles of the calves and thighs to make them contract counter to the heart’s beating. This well-established counterpulsation action results in increased blood flow to the heart muscle while decreasing the heart’s workload. Counterpulsation was previously only available in a clinical setting. Now, m.pulse is the world’s first and only device enabling CHF patients to receive MCP therapy at home.

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