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Medical Devices & Surgical Technology Week
Publisher: CW Henderson
Issue: September 1, 2002
Page: 3

Hypertension
FDA clears breakthrough breathing device to lower blood pressure

2002 SEP 1 - (NewsRx.com) -- Millions of Americans with high blood pressure can now benefit from the first nondrug medical device clinically proven to reduce high blood pressure without side effects.

InterCure, Inc., announced that the device, RESPeRATE, has received clearance from the Food and Drug Administration (FDA) for over-the-counter distribution.

The interactive, device-guided breathing technology used in RESPeRATE is based upon the established scientific evidence that certain breathing exercises, when performed routinely, can lower blood pressure. These therapeutic breathing exercises are difficult to perform properly without the interactive, personalized coaching that RESPeRATE provides.

RESPeRATE has been clinically validated to significantly lower blood pressure by an average of 14 mm Hg systolic and 9 mm Hg diastolic after 8 weeks of routine use (15 minutes per day, 3-4 times per week). Average reductions are even greater for older patients and patients with higher baseline blood pressure. These reductions are in addition to reductions achieved with other therapies.

"RESPeRATE offers an important new option, in fact, a whole new therapeutic class for the adjunctive treatment of high blood pressure," said Henry Black, chairman of the Department of Preventive Medicine at Rush-Presbyterian St. Luke's Medical Center in Chicago and member of InterCure's Scientific Advisory Board. "Physicians and patients have long been searching for an additional effective nondrug therapy, and RESPeRATE is a real breakthrough. It will have a major impact on how high blood pressure is treated."

RESPeRATE, about the size of a paperback book, is battery operated and can be used anywhere. Users place an elastic belt with a respiration sensor around their torso, above the clothing, and wear standard headphones. RESPeRATE automatically analyzes the user's breathing rate and pattern and then interactively guides the user through a therapeutic breathing exercise that effortlessly slows the breathing from a normal rate of 14 to 18 breaths per minute to the "therapeutic zone" of less than 10 breaths per minute with prolonged exhalation.

While breathing returns to normal after each session, the beneficial effects on the blood pressure accumulate and a significant and sustained reduction in blood pressure can be achieved with regular use.

"We are thrilled to be announcing FDA clearance to sell RESPeRATE over the counter. Now the tens of millions of people suffering from high blood pressure have easy access to this remarkable therapy," said Paul Sheils, president and CEO of InterCure. "Patients finally have a nondrug, no-side-effects treatment option to lower their blood pressure that's easy and pleasant to use and can be incorporated safely into their existing hypertension therapies."

This article was prepared by Medical Devices & Surgical Technology Week editors from staff and other reports. Copyright 2002, Medical Devices & Surgical Technology Week via NewsRx.com.