The company’s RESPeRATE device uses breathing therapies to treat hypertension.
Medical devices company InterCure today announced it has received US Food and Drug Administration (FDA) approval to market its RESPeRATE device to lower high blood pressure. The device does not use drugs, and will marketed in the US without a doctor's prescription. InterCure claims this is the first FDA approval for an over-the-counter non-drug treatment for hypertension.
InterCure will begin marketing the device in the US this week through its US subsidiary to consumers for $299. The device is based on the medical knowledge that certain therapeutic breathing exercises can significantly lower blood pressure. The exercises reduces the body’s sympathetic neural activity and relaxing the muscles surrounding small blood vessels, allowing blood to flow more freely.
The device is designed for home operation by the patient. It contains earphones and a reparatory sensor placed on the chest. The device analyses the patient's breathing rate and pattern to create a personalized melody composed of two distinct tones – one tone for inhalation, one for exhalation.
In clinical trials, InterCure found that daily use of the device resulted in 14/9 mmHg average sustained blood pressure reductions within 8 weeks.
InterCure develops non-pharmaceutical interactive breathing therapy devices for cardiovascular and pulmonary diseases.
Published by Globes [online] - www.globes.co.il - on July 16, 2002