FDA-approved medical device consistently measured HR, SaO2, VO2, VCO2, Fb, VT, and PetCO2
Minneapolis-St. Paul, MN (August 25, 2009) – All results from a recent Mayo Clinic study validate the measurement accuracy of the Shape-HF™ Cardiopulmonary Testing System. Data collected by the Shape-HF™ compared favorably to that of the Mayo Clinic Cardiopulmonary Research System and reflected a tight reproducibility of the results. The Shape-HF™ is a new, non-invasive medical device that assesses heart-lung interaction and ventilation in patients with chronic heart failure and other cardiopulmonary disease.
The study involved testing 22 subjects simultaneously on the Shape-HF™ and the Mayo Clinic Cardiovascular Research System. Pneumotachs providing air flow to the respective test sytems were connected in series for the tests. The order of the pneumotach for each system was alternated for two test runs separated by 15 minutes of rest. Each subject was tested at rest and as power was increased on a cycle ergometer to 50 Watts, 70 Watts and 125 Watts, with three minutes of exercise at each exercise work rate.
The last 30 seconds of data for each interval for each run was then averaged. The averages of all subjects for rest and the three exercise intervals were then averaged for each run. The average values for each run showed a remarkably consistent parallel and match for all measurements, which included heart rate (HR), oxygen uptake (VO2), carbon dioxide output (VCO2), tidal volume (VT), end-tidal partial pressure of carbon dioxide (PetCO2), oxygen saturation (SaO2), and breathing frequency (Fb). Prior to each test run, the Mayo system was calibrated manually; the Shape-HF™ was calibrated automatically using its proprietary dynamic autocalibration feature that does not require manual calibration prior to testing. A manuscript detailing the study is in development and will be submitted for publication.
Shape-HF™ is the first gas exchange testing 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. Shape-HF™ quantifies the severity of dyspnea on exertion and fatigue and evaluates 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. 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 help physicians optimize CRT at exercise levels consistent with patient daily activity. Importantly, Shape-HF testing is cost-effective 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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