Innovative Non-Drug, Non-invasive Hypertension Treatment Device Receives NHS Stamp of Approval
LONDON, February 1, 2012 /PRNewswire/ --
From today, RESPeRATE: the interactive respiratory modulator clinically-proven to lower blood pressure - will be available to all hypertensive patients on NHS prescription. Used by patients for just 15 minutes a day, at least four times a week, RESPeRATE has demonstrated a significant, all-day blood pressure reduction beyond that seen with concurrent treatments including medication, diet and exercise.
The NHS decision to make the £200 medical device available to patients on prescription at the standard prescription rate is a clear reflection of the Department of Health's belief in RESPeRATE's potential as a new treatment option.
RESPeRATE was approved after a six-month review of its ten supporting clinical studies (five of which were randomised, controlled), patient satisfaction analyses and cost-benefit economic models and is featured in a new sub-section of Part IXA - Surgical Appliances' of the Tariff list: 'Devices for the adjunctive treatment of hypertension'. RESPeRATE met all DoH requirements for safety, quality, appropriateness and cost effectiveness.
Dr Benjamin Gavish, inventor of RESPeRATE and Chief Scientist of InterCure (manufacturer of RESPeRATE), said: "We are delighted that patients in the UK can now obtain RESPeRATE on prescription. We hope that this pioneering move by the NHS to set up a new device category to supplement the currently available treatment options for hypertension will encourage GPs to integrate RESPeRATE into their hypertension standard of care."
RESPeRATE is primarily recommended for patients who:
- are aged 65+ with not-yet-at-target blood pressure - in spite of medication
- have diabetes with hypertension
- are diagnosed with isolated systolic hypertension
- have refractory hypertension
- refuse medication or experience side-effects
There are no known contraindications for, and have been no adverse reactions to RESPeRATE.
RESPeRATE is also available for patients wanting or able to self-pay, at a cost of £200 either direct from the manufacturer (http://www.resperate.co.uk) or through selected pharmacies.
NOTES TO EDITORS
About RESPeRATE®
RESPeRATE is a non-drug, portable, battery operated, medical device clinically-proven to lower blood pressure.
- It consists of a small computerised control unit, a breathing sensor mounted on an adjustable strap for wrapping around the abdomen and a set of earphones.
- RESPeRATE enables patients to harness the power of therapeutic breathing, to reduce neural sympathetic activity to dilate constricted blood vessels which in turn helps to lower blood pressure - all patients have to do is breathe along with RESPeRATE.
- Its breathing sensor, placed on the upper abdomen, automatically analyses the patient's breathing pattern and in real-time creates a personalised melody composed of two distinct tones - one for inhalation, the other for exhalation - the 'guiding tones'.
- The patient simply listens to the melody through the headphones, and the body's natural tendency to follow external rhythms enables the patient to quickly and easily synchronise his/her breathing to the guiding tones.
- By gradually prolonging the exhalation tone to slow down breathing, RESPeRATE leads the patient to the therapeutic zone of less than 10 breaths per minute. Within a few minutes, the muscles surrounding the small blood vessels in the body relax, blood flows more freely, and blood pressure gradually starts to lower.
- While breathing returns to normal after each session with RESPeRATE, the beneficial impact on blood pressure accumulates. Within three to four weeks, a significant, lasting reduction in blood pressure occurs.
- For more information visit: http://www.resperate.co.uk
About the NHS Drug Tariff approval
- RESPeRATE was approved by the NHS Prescription Service after a six-month review of its ten supporting clinical studies (five of which were randomised, controlled), patient satisfaction analyses and cost-benefit economic models. It will be featured in a new sub-section of Part IXA Surgical Appliances of the Tariff list: 'Devices for the adjunctive treatment of hypertension'.
- The Drug Tariff is a monthly publication issued by NHS Prescription Services of the NHS Business Services Authority (NHSBSA) on behalf of the Secretary of State for Health. The Drug Tariff contains a list of drugs, appliances, devices, chemical reagents etc approved for prescribing at NHS expense by an appropriate practitioner.
- Products must meet the following three criteria for inclusion in Part IX of the Drug Tariff:
- The products are safe and of good quality;
- They are appropriate for GP and, if relevant, non-medical prescribing;
- They are cost effective.
For more information on…
- NHS Prescription Service visit: http://www.nhsbsa.nhs.uk/PrescriptionServices.aspx
- The NHS Drug Tariff visit: http://www.drugtariff.co.uk
- The Department of Health's commitment to early adoption of medical technologies see 'Innovation Health and Wealth - Accelerating Adoption and Diffusion in the NHS'; A report by the DoH published on 5/12/11 at: http://www.dh.gov.uk/health/category/publications
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