Wed Jul 17, 5:26 PM ET
WASHINGTON (Reuters Health) - A device that helps people bring down their blood pressure by doing breathing exercises has received approval from the US Food and Drug Administration ( news - web sites) (FDA) for sale over the counter, the devices maker reported Wednesday.
The device, called Resperate, is made by InterCure Inc. It is a battery-operated device that measures the users respiratory rate and guides him or her through breathing exercises aimed at lowering blood pressure.
The FDA first approved Resperate in May 2000 for stress reduction. The agency also said the device could be prescribed as part of high blood pressure treatment, if used under the guidance of a physician.
FDAs supplementary approval makes Resperate available without a prescription, which InterCure Inc. said would ease access to the alternative treatment for millions of Americans with high blood pressure.
The company added that in clinical trails, Resperate was shown to reduce blood pressure by an average of 14 mm Hg systolic and 9 mm Hg diastolic after 8 weeks of routine use, or three to four times a week for about 15 minutes per day. Systolic pressure is the upper number in a blood pressure reading, while diastolic is the lower figure.
A corporate spokesperson told Reuters Health the device would cost around $299, and that approximately 300 have been sold so far, mostly through word of mouth.
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