[ Back to EurekAlert! ] Public release date: 17-Jan-2001
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Contact: John Pontarelli
jpontare@rush.edu
312-942-5949
Rush University Medical Center

First FDA approved, non-drug treatment for high-blood pressure now available

Initial use of the medical device in the U. S. is only in the Chicago area

A new medical device that can help lower blood pressure with no side effects is now available in the United States by prescription exclusively in the Chicago area. The device, called RespeRate™, analyzes a patient's breathing, then creates sound patterns that guide the patient to through breathing exercises to lower his or her breathing rate. Following each 15-minute exercise, the usual breathing rate resumes. Within a few weeks of use, blood pressure can be lowered with no side effects.

Doctors at Rush-Presbyterian-St. Luke's Medical Center issued the first prescriptions for the device to hypertension patients late in November.

It is the first medical device cleared for marketing by the federal Food and Drug Administration (FDA) for use as an adjunctive treatment for high blood pressure. It is used only under the direction of physicians, together with other medical or non-drug treatments such as diet and exercise. The device is manufactured by InterCure, Inc., a medical device company founded in Israel and headquartered in New York.

To use the RespeRate device, a patient places an elastic belt with a sensor around the mid-section and wears a set of headphones. The sensor and headphones are connected to the small, lightweight RespeRate device (slightly larger than a portable compact disc player) that is set on a table. A processing unit built into RespeRate analyzes the patient's breathing and then creates sound patterns that guide the patient to inhale and exhale at a lower rate best suited for that patient.

Slow and deep breathing is well known to regulate both cardiovascular and nervous systems. The greater lung inflation associated with deep and slow breathing stimulates slowly adapting pulmonary stretch receptors in the cells of the lungs, which leads to blood pressure reduction.

"This device and its related program encourages compliance with daily breathing exercises that are individually customized to adjust the breathing pattern of each patient to one which we know can lower blood pressure," said Dr. Henry Black, chairman of the department of preventive medicine and associate vice president for research at Rush-Presbyterian-St. Luke's Medical Center. "It represents a effective new tool for doctors and patients to treat hypertension."

Black is certified as a specialist in hypertension by the American Society of Hypertension and has been on the executive committee of the American Society of Hypertension and the Council on High Blood Pressure Research of the American Heart Association.

The prescription for RespeRate also includes a blood pressure monitor that automatically measures blood pressure and stores readings as well as computer link cables that enable patients to connect their personal computer to the RespeRate device and blood pressure monitor. Once connected, patients can transfer data to a secure Internet-based website sponsored by InterCure that provides a personalized reporting system for recording treatment activities and blood pressure reading.

The results of three randomized, doubled-blinded clinical studies support the use of the device. The studies showed that use of the RespeRate device along with prescribed hypertension drugs resulted in a typical reduction of 12mmHg systolic and 8mmHg diastolic in just six weeks of daily treatment.

The blood pressure reduction was achieved both with patients in the study who were taking prescribed hypertension drugs, and those who were not taking the drugs. The reduction in blood pressure using RespeRate is similar to the reduction achieved using various drugs, but with no side effects.

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Hypertension affects over 50 million Americans, or nearly one in four adults. If left untreated, hypertension raises the risk for developing cardiovascular diseases such as heart attack, congestive heart failure and stroke. Cardiovascular diseases are responsible for more deaths each year than the next seven leading causes of death combined. According to the American Heart Association, only 27 percent of people with high blood pressure have their disease under control.


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