IQoro (MYoroface AB) is a neuromuscular training device and exercise regime used to relieve symptoms related to hiatus hernia by strengthening the oesophagus and diaphragm.
The device is made of acrylic and consists of a crescent-shaped panel that sits between the teeth and lips and a handle for pulling. The panel, or screen, is gripped between closed lips and the teeth and the handle is pulled outwards with the hand. To exercise, the user presses their lips together and pulls forward strongly for 5 to 10 seconds, repeating the exercise 3 times with 3 seconds of rest between repetitions. Training should be done 3 times each day, preferably before meals. People who cannot grip the device between their lips can use a 'jaw grip' technique. This involves the user using their fingers to pinch their lips closed while pulling with the other hand. People who cannot use the jaw grip technique can be helped by a carer. The device can be washed using soap and water, with toothpaste or in the dishwasher. IQoro is available in 2 sizes (small for children and large for adults).
The product is marketed for use in people with dysphagia and in people with a hiatus hernia and reflux symptoms. This briefing focuses on IQoro for treating people with hiatus hernia. NICE has also published a medtech innovation briefing on IQoro for stroke-related dysphagia.
IQoro is unique in treating hiatus hernia through an exercise regime with an oral device. The device aims to relieve the symptoms of the condition after 3 to 6 months of use. The exercise regime is designed to permanently strengthen the musculature of the hiatus, addressing the underlying cause of hiatus hernia without needing surgery or long courses of medication.
NICE's guideline on gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management recommends offering a full-dose proton pump inhibitor (PPI) long-term as maintenance treatment for people with severe oesophagitis (reflux disease).
Laparoscopic fundoplication should be considered for people who have a confirmed diagnosis of acid reflux and enough symptom control with acid suppression therapy but who do not wish to continue with this therapy long term. It should also be considered in people who have a confirmed diagnosis of acid reflux and symptoms that are responding to a PPI, but who cannot tolerate acid suppression therapy.
IQoro would be used to improve symptoms by attempting to address the underlying cause of hiatus hernia. This could potentially remove the need to take PPIs or to have surgery.
IQoro is intended for treating symptoms related to hiatus hernia, such as misdirected swallowing, hoarseness, chest pain, chronic cough and a feeling of a lump in the throat (globus).
IQoro is intended to be used in a hospital, the home or community setting. In most cases the exercise is done by the user after initial self-instruction. In a few cases initial demonstration by a healthcare professional may be necessary. A carer can help if the patient lacks upper limb mobility or dexterity. The carer does not need to be a healthcare professional.
The cost of a single IQoro device is £116 (excluding VAT). The cost per unit is lower if the devices are ordered in bulk. There are no consumables or licence fees.
People with severe oesophagitis (reflux disease) stay on a course of full-dose PPIs mainly prescribed by GPs in primary care in the long term. This would result in an approximated cost of between £18 and £60 per person per year.
Laparoscopic fundoplication can provide better long-term outcomes and although the initial cost is £2,076, it can also provide cost savings compared with PPI maintenance. This is because people who have had surgery will no longer need PPIs and there will be a decrease in visits to GPs and hospital attendances.
Costs of standard care taken from the costing statement for NICE's guideline on gastro-oesophageal reflux disease and dyspepsia in adults, published in 2014.
IQoro may be resource releasing compared with long-term PPI maintenance. It also has a cheaper up-front cost than laparoscopic fundoplication.
According to the company, there are around 10,000 users of the device and around 500 of these are in the UK. Many UK users have purchased the device privately. The company states that over half of this population are using IQoro for hiatus hernia.
No published evidence was found on the resource consequences of adopting the technology.
No practical difficulties or changes in facilities and infrastructure are associated with adopting the technology.