New FDA-Approved Medical Device Objectively Measures Heart/Lung Interaction to Evaluate Patient Functional Capacity, Therapy Response and Risk
Minneapolis-St. Paul, MN (PRWeb) April 14, 2009 -- Dr. Dean A. Bramlet, the Director of the Cardiovascular Diagnostic Center of the Heart and Lipid Institute of Florida located in St. Petersburg, a Diplomate of Clinical Lipidology, and an Assistant Consulting Professor of Medicine at Duke University, is the first physician to acquire 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. Having received FDA approval earlier this month, Shape-HF is the first of its kind being introduced to cardiologists across the country. While ventilation 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 easy to use, easy on the patient, and provides clinically relevant data that is easy to understand, reproducible and immediately useful to a cardiologist.
With over 30 years of experience treating patients and conducting clinical research in the area of heart failure and related disease--his clinical research in cardiovascular resynchronization conduction disturbances has advanced the use of Cardiac Resynchronization Therapy (CRT) in heart failure--Bramlet is always looking for ways to alleviate symptoms for his patients. "Until now we have not had an objective way to measure a heart patient's response to therapies. The Shape-HF allows cardiologists to optimize therapy and minimize symptoms for patients. It is simple to use and will quantifiably measure a patient's breathing and tolerance to exercise without putting the patient through undue stress," says Bramlet.
Cardiologists know that measuring patient ventilation is the best method of assessing patient functional capacity, monitoring their response to therapy and predicting outcome. According to Shape Medical Systems President and CEO 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."
Objective Data. The Shape-HF quantifies shortness of breath, allows serial tracking of patient progress, measures patient response to therapy, offers objective criteria for patient functional classification, correlates with biochemical markers of heart failure (BNP and ANP), and provides data that is predictive of patient mortality and hospitalization risk. Using patented methods and protocols, the device can also help physicians define response to CRT. Shape-HF is the first device designed to provide real time physiological data to physicians that can be used to optimize CRT therapy response while the patient is exercising to a level of normal daily activities.
Easy on Patients. 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.
Easy to Use. Testing with Shape-HF is intuitive, easy to interpret and can be performed by clinic employees without direct physician supervision.
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. Shape-HF and 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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