Cardiola has collaborated with the Heart and Diabetes Center North Rhine-Westphalia, Ruhr University of Bochum, Bad Oeyhausen, Germany, in a study of the company’s CE-marked m.pulse system. The study’s purpose is to investigate the utility of 'Muscular CounterPulsation' (MCP) in patients with early-stage heart failure.
MCP was previously available in only a clinical setting. Currently, as Cardiola claims, m.pulse is the first device enabling chronic heart failure (CHF) patients to receive MCP therapy at home.
The company also reported that data from a study presented at 2009 Annual Congress of the Swiss Society of Cardiology concluded that ‘MCP is safe and efficient for improving cardiac function’ non-surgically in patients with coronary artery disease (CAD).
The 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. This well-established MCP action results in increased blood flow to the heart muscle, while decreasing the heart’s workload.
Christof Lenz, CEO of Cardiola, said: “We are extremely pleased to be collaborating with one of the leading heart centers and interventional cardiologists in Europe. Under the supervision of the clinical investigating team, early-stage heart failure patients will be able to use our m.pulse system at home on a prescribed schedule and will be evaluated to determine the impact of m.pulse treatment on their symptoms of CHF. 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.
“While m.pulse is already CE-Marked and safety has been established, this study is intended to offer additional clinical evidence of m.pulse as a well-validated, affordable and non-surgical treatment option that patients themselves can perform in their own home.”