First Low-Intensity Medical Device to Objectively Quantify Cardiopulmonary Response to Exercise; Simple Test Done in Office, Shape-HF Helps Doctors Distinguish Between Cardiovascular and Ventilatory Limitations
By Elise Schadauer

Minneapolis-St. Paul, MN (July 14, 2010) -- Shape-HF is a new non-invasive, low-intensity cardiopulmonary exercise testing device used to assess functional status in patients showing symptoms of heart or lung disease. Exertional dyspnea is complex and arises from multiple neuromuscular, hormonal, myopathic, metabolic and psychogenic pathophysiologies. Shape-HF quantifies the severity of dyspnea and fatigue on exertion and evaluates the interaction between the heart, lungs, and other organ systems involved in oxygen uptake and transport. Functional tests performed at rest cannot reliably uncover the underlying mechanisms of exercise intolerance in patients with chronic cardiac or pulmonary disorders.

Shape-HF links measured functional performance and the physiology contributing to exercise limitation and dyspnea. Test results help physicians in:

  • Diagnosing, treating and monitoring chronic heart and pulmonary conditions, including pulmonary hypertension and right-to-left exercise-induced shunting
  • Assessing the physiology of unexplained dyspnea
  • Evaluating and optimizing cardiac pacemaker and ventricular assist device function
  • Determining the timing for specialized therapy or transplant

 

Until now, obtaining this relevant clinical information has been out of reach for most clinical practices. The cost and logistics of performing such tests, the complexity of testing and data interpretation, and the significant level of patient discomfort associated with testing have acted together to limit their utility.

 

Testing is simple, intuitive and can be performed by clinic employees with limited supervision.

 

Shape-HF offers three standard test protocols so even high risk patients can be tested with minimal discomfort. Exercise options range from low intensity to peak exercise using a step test, treadmill, or cycle ergometer. A pre-populated result interpretation aid makes it easy to interpret test results and a final report summarizes patient data, provides objective insight of patient functional class, and shows a trend plot of previous test results, making it easy to monitor therapy efficacy. Shape-HF is FDA-approved and has been clinically validated against the most sophisticated research grade cardiopulmonary exercise testing systems.

 

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 testing provides evidence based outcomes.  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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