Cardiola Receives CE Mark Recertification of its m.pulse System for at-Home Use
Published: May 12, 2009
BUSINESS WIRE--Cardiola AG announced today that it has 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+.
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. 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 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.
The Company also announced that it has appointed Walter Lange as Chief Operating Officer (COO) and Josef Jungert as Vice President of Sales. In addition, the Company has hired four direct sales representatives.
As Chief Operating Officer for Cardiola, Mr. Lange brings in-depth production and supply chain management experience from his previous management positions. For example, prior to joining Cardiola, he was Head of Product Management at Egro Coffee Systems and Siemens Building Technologies. Mr. Lange studied computer science at the Technikerschule in Winterthur, Switzerland, and business administration at the Kaderschule, St. Gallen, Switzerland. He is fluent in German, English, Spanish and French.
Josef Jungert is an industry veteran with more than 30 years of experience in sales and marketing of medical devices. He was an advisor to Cardiola prior to joining the Company as Vice President of Sales. Mr. Jungert began his career in sales management positions at 3M and General Electric Medical Systems. Other experience included Wesley Jessen and PLC Medical Systems. Prior to joining Cardiola, he was Director of Sales Aesthetics for WaveLight (dermatology and aesthetic laser systems).
“Clinical evidence, published in peer-reviewed medical journals, has demonstrated that MCP—the proprietary technology platform of our patented m.pulse® device—facilitates timely and effective therapy, improving outcomes for CHF patients,” said Christof Lenz, Cardiola’s CEO and former Global Innovation Manager at Siemens Medical. “We are extremely pleased that our m.pulse® system has been cleared for marketing in Europe as a well-validated, affordable and non-surgical treatment alternative that patients themselves can perform in their own 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.
Ronald Trahan Associates Inc. Ronald Trahan, APR, 508-359-4005, x108