New York, N.Y. -- From today, RESPeRATE, the $300 respiratory modulator clinically-proven to lower blood pressure becomes the first non-drug hypertension treatment to be reimbursed by UK's National Health Service (NHS) Drug Tariff under a newly created sub-section 'Devices for the adjunctive treatment of hypertension.
The NHS pioneering decision to set up a new medical device category to supplement the available, reimbursed treatment options for hypertension follows a detailed six-month review of clinical data and cost benefits analysis.
The decision is likely to significantly improve access to the non-drug, non-invasive RESPeRATE among the 8 million British patients whom do not have their blood pressure at target despite availability of anti-hypertensive medications.
High blood pressure affects around 1 in 3 adults in the developed world. Despite many recent advances in the medical treatment of hypertension and numerous public health campaigns aimed at highlighting awareness of the dangers of high blood pressure, it remains the number one risk factor for death - through heart disease and stroke,
Used by patients for 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.It works by reducing sympathetic outflow – a technique employed by a number of otherrecently developed invasive technologies for treating hypertension including renal sympathetic nerve ablation and baroreceptor stimulation
ErezGavish, CEO of InterCure (manufacturerof RESPeRATE), said: "We are delighted with RESPeRATE's NHS Drug Tariff listing. It demonstrates the proliferation of the device-based treatment paradigm into the hypertension market. We hope that this NHS 'stamp of approval' will encourage additional countries to follow suit and physicians 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
RESPeRATE is available outside of the UK for patients wanting or able to self-pay, at a cost of $300 direct from the manufacturer (http://www.resperate.com).
CONTACT
For further information or to request an interview with:
Dr Benjamin Gavish, inventor of RESPeRATE and Chief Scientist, InterCure ; or ErezGavish, CEO, InterCure, manufacturer of RESPeRATE please call Dr Nicky Cardoe on 646-562-5800 ext. 5607.
About RESPeRATE®
RESPeRATE is a non-drug, portable, battery operated, medical device clinically-proven to lower blood pressure.
It consists of a small computerizedcontrol 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 personalized 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 synchronize 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/clinicians
About the NHS Drug Tariff approval
RESPeRATEwas approved by the NHS Prescription Service after a six-month review of its ten supporting clinical studies (five of which were randomized, 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 ServicesAuthority (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…
Other companies with relevant device-based hypertension treatments - renal sympathetic nerve ablation (MDT:US); Baroreceptor stimulation (CVRx, Privately held)
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