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Cardiola Presents Clinical Study Demonstrating m.pulse System

Cardiola has reported that its CE-Marked m.pulse Muscular CounterPulsation (MCP)-based system demonstrated 'an immediate improvement of cardiac output with non-invasive means' in a patient population of advanced yet stable chronic heart failure. The effects could be shown in 22 patients over three consecutive days.

Cardiola said that the key conclusions of the study presented at the Congress were: MCP was able to improve acutely the cardiac output in 22 patients with stable CHF in a three-day follow-up period; There was no interference from MCP with electronic implants such as ICD or CRT (‘pacemaker’) systems; There was no negative influence from MCP on myocardial integrity (as measured by troponin, CK, CK-MB).

The company has reported that data from a study presented at Annual Congress of the Swiss Society of Cardiology, 2009, concluded that ‘MCP is safe and efficient for improving cardiac function’ non-surgically in patients with coronary artery disease (CAD).

In the study, peripheral resistance of CAD patients was decreased by 22%; end-diastolic pressure was reduced by 18%; and stroke work was reduced by 16%. Additionally, there was a 12% increase in cardiac index. Equally important, all of these hemodynamic effects were less marked in the study’s control patients.

Cardiola’s m.pulse device, based on Muscular CounterPulsation (MCP) technology, is approved in Europe for treating CHF as a non-surgical, at-home therapy. Battery-powered m.pulse, the size of a cell phone that the patient attaches to his belt for about 45 minutes per treatment, is synchronized to his cardiac cycle to stimulate the muscles of the calves and thighs to make them

contract in the resting phase of the heart.

The Muscular CounterPulsation action results in increased blood flow to the heart muscle while decreasing the heart’s workload. MCP was previously only available in a clinical setting. Thus, m.pulse device enabling CHF patients to receive MCP therapy at home.

Christof Lenz, CEO of Cardiola and former global innovation manager at Siemens Medical, said: “We are pleased with the results of this important study at one of the leading heart centers by one of the preeminent interventional cardiologists in Europe. It has been well-documented clinically that MCP, the proprietary technology platform of our patented m.pulse device is a safe and effective therapy designed to improve the hemodynamic function of a failing heart.

“Of course, m.pulse is already CE-Marked and safety has been established. Nevertheless, this study opens up additional indications in an acute setting and certainly offers further clinical evidence of m.pulse as a non-surgical treatment option for patients with stable CHF.”