Dr. Reece’s Pieces – Medinnovation Blog – May 12, A Simple, Portable Device To Find Causes of Shortness of Breath and to Ascertain Its Magnitude

Patients often present in a doctors office complaining of dyspnea. Is it simply shortness of breath from being out of shape? Or it something worse – chronic bronchitis, emphysema, coronary artery disease? How severely is respiratory function compromised? Can the degree of lung dysfunction be measured? Is it related to heart disease? These are questions the doctors may ask.

Now there is a simple, portable device doctors can use to get at the source of dyspnea - pulmonary or heart - and to measure its magnitude without subjecting the patient to the risk of a traditional coronary stress test entailing treadmill testing.

The device, the Shape-HF Cardiopulomary Exercise Testing System, is designed for use in physician offices. It gives doctors a window into patient physiology. It helps pinpoint the source of dyspnea limitation. The doctor then can make informed decisions on patient status, diagnosis and therapy options.

Further, doctors may monitor patient progress over time, adjust therapy, track the response, and see the impact of therapy decisions often before an overt change in patient symptoms. In patients with pacemakers or in cardiac resynchronization therapy, Shape-HF helps assess rate response. It can be used to help doctors optimize coronary rates while the patient is upright and exercising to a level consistent with the activities of daily living.

The device 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 the physician.

The basic components of Shape H-F include a disposable snorkel-like mouth piece which collects expired respiratory air and connects to a data gas analyzer. The analyzer has a built in pulse oximeter which uses either a finger or ear lobe probe to measure the patient’s heart rate and blood oxygen saturation. The data downloads into a laptop computer. The laptop contains software based on population data to predict chances of hospitalization, deat, and response to drugs. The system is low cost, can be carried in a small duffel bag, and can be performed by one trained technician.

Shape Medical Systems Inc. is a privately held, St. Paul, Minnesota-based medical device company that develops and commercializes products for assessing heart/lung interaction and ventilation in chronic heart failure and other cardiopulmonary disease. Shape's develops 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 and pending. issued