m.pulse system for MCP therapy installed in ten hospitals

Cardiola AG announced today that it has placed its patented m.pulse® system in 10 hospitals located in Germany and Switzerland, on the heels of the system’s CE-Mark approval. MCP was previously only available in a clinical setting. Now, m.pulse® is the world’s first and only device enabling CAD patients to receive MCP therapy at home.

Previously the Company announced that data from a study presented at the recently convened Annual Congress of the Swiss Society of Cardiology concluded that “MCP (Muscular CounterPulsation) 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.

“We are extremely pleased with our headway in penetrating the European market with our breakthrough m.pulse® system, based on Muscular CounterPulsation or MCP, for the non-surgical treatment of Coronary Artery Disease. Certainly, it is 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,” said Christof Lenz, Cardiola’s CEO and former Global Innovation Manager at Siemens Medical. “Ten hospitals in Germany and Switzerland are now using the m.pulse® system on a regular basis, thus giving their patients a well-validated, affordable and non-surgical treatment option that patients themselves can perform in their own home. We expect to report considerably more progress in our goal to ensconce m.pulse® across Europe as standard adjuvant care for treating CAD at home.”

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. This well-established 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. Now, m.pulse® is the world’s first and only device enabling CHF patients to receive MCP therapy at home.

Chronic Heart Failure is among the world’s most prevalent diseases and the cause of numerous other serious clinical disorders. Approximately 17 million people currently suffer from CHF in Europe, the U.S. and Japan. Some six million of these patients are classified as NYHA (New York Heart Assn.) classes II and III with systolic dysfunction, the primary patient population for m.pulse® with Muscular CounterPulsation from Cardiola.