ATLANTA – (March 26, 2008) -- For heart failure patients, just getting through the simplest activities of daily life sometimes presents big challenges: moving from the bedroom to the kitchen for a morning cup of coffee can leave them breathless; climbing a set of stairs may be nearly impossible; walking to the mailbox can be exhausting. Diet and daily medications affect the condition and slight changes can cause these patients’ lungs to fill with fluids, a condition called “decompensation.” When decompensation occurs, patients are typically hospitalized and treated with medications to reduce the fluid overload. Some heart failure patients may be hospitalized many times each year for this condition.
Heart Failure affects more than five million people in the U.S. and is the most common cause of hospitalizations for people over 70 years of age. In 2007, the estimated direct and indirect costs of managing heart failure in the U.S. was approximately $33 billion, and the number of patients with heart failure is expected to double in the next 30 years.
Saint Joseph’s Hospital is looking for better ways to care for heart failure patients who come from throughout the state. Recently, Saint Joseph’s Hospital enrolled its first patients into a new clinical trial designed to remotely monitor heart failure patients with the intention of reducing heart failure-related hospitalizations. The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) pivotal clinical trial studies the safety and effectiveness of the CardioMEMS Heart Failure (HF) Pressure Measurement System in reducing HF-related hospitalizations in HF patients. The study was initiated in September, 2007, and will enroll 550 patients in the United States. Saint Joseph’s was the only site in the Southeast to participate in the initial feasibility study and the Saint Joseph’s Research Institute was instrumental in the preclinical development of the pressure sensor device.
The device being studied in the CHAMPION trial is a Wireless HF sensor. It is a proprietary miniature device designed and developed by Atlanta-based CardioMEMS, Inc. The sensor – the size of a grain of rice -- is implanted into a patient’s pulmonary artery using a simple, catheter-based procedure and requires one overnight stay at the hospital. The patients then use home electronics to wirelessly collect data from the implanted sensor and the pressure data is transmitted through the patient’s telephone line to a database that is available for review by the physician on a secure website. The trial will study whether this data can be used by physicians to help monitor the status of the patient’s heart, adjust his/her medications when required, and if these actions might result in a reduction in hospitalizations for HF patients.
The study’s principal investigator at Saint Joseph’s Hospital is Nicolas Chronos, MD, cardiologist and president, Saint Joseph’s Translational Research Institute.
“We believe this remote monitoring device may be a benefit for heart failure patients who live beyond urban areas and typically must travel some distances to be admitted to the hospital to monitor these vital pressure measurements,” says Dr. Chronos. “In addition, the experimental device may reduce the frequency of invasive catheter procedures, hospitalizations and improve the patient’s quality of life.” The Co-Principal Investigators of the CHAMPION pivotal trial are Philip Adamson, MD, director of the Heart Failure Institute, Okalahoma Heart Institute and William Abraham, MD, director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.
Jay Yadav, MD, chairman and CEO of CardioMEMS, Inc. commented, “Saint Joseph’s Hospital is one of the largest cardiac care programs in the country and is well established as a leader in quality of care. CardioMEMS is very pleased to be collaborating with Dr. Nicolas Chronos and the heart failure specialists at Saint Joseph’s Hospital on this clinical trial.
About CardioMEMS,Inc.
CardioMEMS is a medical device company that has developed and is commercializing a proprietary wireless sensing and communication technology for the human body. Our technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. Our miniature wireless sensors can be implanted using minimally-invasive techniques and transmit cardiac output, blood pressure and heart rate data which are critical to the management of patients. Our sensors are designed to be permanently implanted into the heart and blood vessels due to their small size, durability, and lack of wires and batteries. Using radiofrequency, or RF, energy, our sensors transmit real-time data to external electronic readers which then communicate this information to the patient’s physician. We believe frequent, on-demand, real-time monitoring of vital information enables proactive patient management, which holds the promise of reducing hospitalizations, improving a patient’s quality of life and delivering more efficient and cost effective health care. CardioMEMS is located in Atlanta, GA and is privately held. More information about the company can be found at www.cardiomems.com.
CardioMEMS is a trademark of CardioMEMS, Inc.
