DESCRIPTION

The RESPeRATE device is a non-invasive, non-drug therapeutic device to perform breathing exercises as an adjunctive treatment for hypertension. It includes a miniature-processing unit, headphones, and a respiration sensor on an elastic belt.

CLINICAL PHARMACOLOGY

The results of three randomized, controlled clinical studies (1-2) support the use of RESPeRATE. The studies showed that the use of the device along with prescribed hypertension medications resulted in a typical reduction of 12mm Hg systolic and 8mmHg diastolic in just six weeks of daily treatment. Pooled trial data, as well as additional trial data (3) , also have shown that this blood pressure reduction increases both with age and with higher initial blood pressure (1-3) . Use of the device has been shown to lower blood pressure with patients who were taking hypertensive medications as well as in those who were not taking medication to control blood pressure. No side effects or adverse reactions were reported.

INDICATIONS AND USAGE

The RESPeRATE device is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure under the direction of a physician, together with other pharmacological and/or non-pharmacological interventions as prescribed by the physician.

CONTRAINDICATIONS

None known.

PRECAUTIONS

Do not use RESPeRATE when you need to be alert, or to concentrate, or when using heavy equipment. Do not use RESPeRATE while driving. Breathe naturally throughout the exercise. Excessive deep breathing may cause dizziness and palpitations. This device has not been studied in patients with respiratory disease, diabetes, atrial fibrillation, active ischemic heart disease/unstable angina, congestive heart failure, stroke, chronic renal failure, or major organ failure.

DOSAGE AND ADMINISTRATION

Physicians should write a prescription and fax it to the mail order pharmacy @312-421-5082. Patients should call 877-988-9388 for delivery.

REFERENCES

  1. Schein M, Gavish B, Herz M, et al. "Treating hypertension with a device that slows and regularizes breathing: a randomized double-blind controlled study." J Human Hypertens 2001 15(4):271-278.
  2. Grossman E, Grossman A, Schein MH, et al. "Breathing control lowers blood pressure." J Human Hypertens 2001 15(4):263-269.
  3. Rosenthal T, Alter A, Peleg E, Gavish B. "Device guided breathing exercises reduce blood pressure-ambulatory and home measurements." Am J Hypertension 2001:14:1:74-76.

InterCure, Inc.

214 Carnegie Center Suite 300

Princeton, NJ 08504

Direct Inquiries to:

Phone: 609-799-7599

Fax: 609-799-7690

Sales and Ordering:

Customer Support Center

(877) 988-9388



Copyright© 2001 Medical Economics