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Low-Intensity Medical Device Objectively Quantifies Cardiopulmonary Response to Exercise

Shape-HF, by Shape Medical Systems Inc., is a new FDA-approved non-invasive, low-intensity cardiopulmonary exercise testing device used to assess functional status in patients showing symptoms of heart or lung disease. The device 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.

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.Testing can be performed by clinic employees with limited supervision, the company stated.

Shape-HF offers three standard test protocols so 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.


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