FDA-approved medical device provides a solution to an unmet clinical need
to objectively optimize heart failure therapy
Minneapolis-St. Paul, MN (June 10, 2009) – Shape Medical Systems, Inc. will be on hand to display its new medical device, the Shape-HF™ Cardiopulmonary Testing System, at the upcoming American Association of Heart Failure Nurses June 25-27 annual meeting in Minneapolis. Given that heart failure accounts for 15 million office visits per year and burdens the healthcare system with costs of more than $30 billion, the Shape-HF™ offers a solution to an unmet clinical need to objectively optimize heart failure therapy.
The Shape-HF™ is a non-invasive medical device that 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. It 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.
Heart failure healthcare professionals know that the main symptoms of chronic heart failure—shortness of breath and fatigue on exertion—are difficult to objectively quantify, making assessment of the presence or severity of the condition largely subjective. 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 to evaluate therapy options for the individual patient and track patient progress. In addition, using the Shape-HF™ to measure changes in patient breathing efficiency as cardiac resynchronization therapy (CRT) settings are adjusted allows physicians to assess the physiological effect of therapy in real time while the patient is exercising at a level consistent with normal daily activity.
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.”
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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