Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, when the Butterfly Health Device Mobius HD to prevent strokes will be available on the NHS.

According to the available information the product is currently undergoing clinical trials to determine safety and performance. We understand that so far there has just been one study in humans, a proof of concept study on 30 patients.

Once these trials have been completed and the manufacturer is able to meet all the other requirements of the medical device directives, they may use the “CE” mark on their product as a medical device. The Medicines and Healthcare products Regulatory Agency is not in a position to advise how long this process will take, as this will be dependent on the manufacturers’ data and their ability to meet the requirements of the relevant regulations.

Before treatments can be made available for patients careful assessments of the evidence for clinical effectiveness and cost effectiveness are needed in order to ensure that the treatment will give patients benefit in clinical practice, with acceptable risk and within established cost effectiveness thresholds. The National Institute for Health and Care Excellence (NICE) will normally review such treatments and make a recommendation on whether they should be used in the National Health Service, by publishing a Technology Appraisal. Commissioners will not usually develop a commissioning policy on treatments in advance of NICE Technology Appraisal.

Although stroke is one of a number of potential complications associated with untreated hypertension, the manufacturer of this device states it is intended to be used to treat resistant hypertension (hypertension which does not respond to drug treatment) and not for stroke prevention.