New FDA-approved medical device “is specifically designed to objectively measure cardiopulmonary gas exchange in heart failure patients. It can make a dramatic difference in treating CRT patients.” Dr. Abraham Kocheril, Professor of Medicine and Director of Clinical Electrophysiology at the University of Illinois at Chicago
Minneapolis-St. Paul, MN (May 6, 2009) – The University of Illinois Medical Center, the primary teaching facility for the UIC College of Medicine (the nation’s largest medical school), is the first such institution to install and begin using the innovative Shape-HF™ Cardiopulmonary Testing System. Developed by Shape Medical Systems, Inc., this non-invasive medical device assesses heart-lung interaction and ventilation in patients with chronic heart failure and other cardiopulmonary disease. While gas exchange testing devices have been used for several years to measure cardiopulmonary response to exercise, Shape-HF™ is the first device specifically designed for cardiology. Shape-HF™ is FDA-approved, easy to use, easy on the patient, and provides clinically relevant data that is easy to understand, reproducible and immediately useful to a cardiologist.
Upon being introduced to the Shape-HF™ System, Dr. Abraham Kocheril, Professor of Medicine and Director of Clinical Electrophysiology at the University of Illinois at Chicago, saw immediate applications for the device. “It broadens the pool of heart failure patients we are able to accurately test because it is less cumbersome than existing cardiopulmonary testing devices and it is patient friendly for those with heart failure,” says Dr. Kocheril. Shape-HF™ uses low intensity, sub-maximal or steady state testing protocols to allow testing of even high-risk patients with little or no discomfort.
Cardiologists know that measuring patient gas exchange is the best method of assessing patient functional capacity, monitoring their response to therapy and predicting outcome. Shape-HF™ is designed to quantify the severity of dyspnea on exertion and fatigue and evaluate the interaction between the heart, lungs, and other organ systems. This makes it possible for the physician to evaluate therapy options for the individual patient and track patient progress. In addition, cardiac resynchronization therapy (CRT) has become a mainstay in treating patients with severe heart failure when alternative treatment options have been exhausted. According to Dr. Koucheril, “The CRT response rate in heart failure patients is about 70%. The Shape-HF™ System is likely to help us get the remaining 30% feeling better—those we call non-responders—because it lets us objectively measure response to CRT and optimize timing between the atrium and the two ventricles of the heart in real time while the patient is exercising.”
In addition to being the first and only device that objectively measures cardiopulmonary gas exchange easily and quickly without undue strain on the patient and in the office setting, Shape-HF™ provides real-time physiological assessment to enable CRT optimization during exercise and is cost-effective and easy to use. According to Shape Medical Systems President and COO Clarence Johnson, “Cost, logistics and the complexity of testing and data interpretation, as well as the significant level of patient discomfort associated with cardiopulmonary exercise testing has limited its utility and deprived physicians and their patients of much needed physiological information. Shape-HF™ overcomes these limitations. It provides objective data to the cardiologist right in the office or clinic. The test is easy on patients and the equipment is intuitive and easy to use.”
Dr. Kocheril is certified by the American Board of Internal Medicine in Cardiovascular Disease and Clinical Cardiac Electrophysiology. He has published extensively, serves as a reviewer for several journals, and is on the editorial board of one journal. He has spoken internationally and takes an active role as faculty in the annual scientific sessions of the Heart Rhythm Society.
The University of Illinois Medical Center is a comprehensive teaching and research hospital and is the state's largest public medical facility. Founded in 1925, the medical center has pioneered dramatic innovations in medical treatment, technology and cutting-edge research with a dedication to patient care. The medical center includes a 507-bed hospital and more than 40 primary care and specialty outpatient clinics. It is associated with UIC's health sciences colleges of medicine, pharmacy, nursing, dentistry, public health and applied health sciences. The hospital serves as the primary teaching facility for the UIC College of Medicine, the nation’s largest medical school, graduating approximately 300 physicians each year. In Illinois, approximately one in six physicians is a graduate of the UIC College of Medicine.
Shape Medical Systems Inc. is a privately held, St. Paul, Minnesota-based medical device company whose core technology lies in the development and commercialization of products for assessing heart/lung interaction and ventilation in chronic heart failure and other cardiopulmonary disease. Shape's clear mission is to develop products that increase the quality of patients' lives by helping doctors quantify shortness of breath, assess patient functional capacity, optimize drug, device and rehabilitation therapy, and monitor patient progress. Shape Medical Systems was founded in 2004 and received FDA market clearance for the Shape-HF™ Cardiopulmonary Testing System in April 2009. The Shape-HF™ System, testing protocols and applications are protected by patent 7,225,022 and other U.S. and foreign patents issued and pending.
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