NICE, the healthcare guidance body, today (30 May) issues guidance on an innovative medical technology device which can benefit patients with complex brain aneurysms - a bulging blood vessel in the brain.

The NICE medical technology guidance supports the use of the Pipeline embolisation device in the NHS when it is used in patients with giant or complex intracranial aneurysms who would need large numbers of coils during stent-assisted coiling and who are unsuitable for neurosurgical treatment.

An aneurysm is a bulge in a blood vessel that'scaused by a weakness in the blood vessel wall. If an aneurysm in the brain ruptures, the resulting haemorrhage can cause death or serious brain damage and symptoms including sudden severe headache, stiff neck and nausea. 1 in 12,500 people will have a ruptured intracranial aneurysm in any given year in England.

The Pipeline embolisation device is a self-expanding blood flow diverter, loaded into and delivered via a microcatheter and placed across the neck of an intracranial aneurysm. Once in place, the blood flow through the parent vessel continues through the device, but the blood flow within the aneurysm sac is disrupted, leading to stagnation until it eventually forms a clot and is excluded from the circulation.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said: "We're pleased to publish this guidance supporting the Pipeline embolisation device for specific patients with giant or complex intracranial aneurysms. The independent NICE Medical Technologies Advisory Committee reviewed the evidence for adopting the Pipeline embolisation device in the NHS, and concluded that it has benefits for patients including a reduction in the symptoms caused by pressure of the bulging blood vessel on the brain, reduced rates of retreatment and a decreased rate of brain haemorrhage. In some clinical scenarios, using Pipeline is expected to save the NHS around £492 per procedure compared with standard treatment.

"We are also very keen for clinicians to submit details of all patients being treated with the Pipeline embolisation device to the UK Neurointerventional Radiology Group audit database, as the guidance recommends. This will increase the evidence base and help guide the future use of this technology."

The guidance Pipeline embolisation device for the treatment of complex intracranial aneurysms is available at www.nice.org.uk/MTG10.

Ends

Notes to Editors

About the guidance

1. The guidance is available at www.nice.org.uk/MTG10 from Wednesday 30 May 2012. Please contact the NICE press office for an embargoed copy of the guidance.

2. The recommendations are:

a) The case for adopting the Pipeline embolisation device in the NHS is supported by the current evidence when it is used in patients with complex giant or large intracranial aneurysms which are unsuitable for surgery and being considered for stenting, and where large numbers of coils would be needed during stent-assisted coiling.

b) The Pipeline embolisation device is estimated to be cost saving when compared with stent-assisted coiling, in patients with complex giant or large intracranial aneurysms when the number of Pipeline embolisation devices inserted does not exceed two, and when treatment would otherwise require the use of 32 or more coils combined with one stent for stent-assisted coiling. If two Pipeline embolisation devices are used the total procedure cost is estimated as £30,346 compared with £30,838 for the use of 32 coils for stent-assisted coiling (a saving of £492 using the Pipeline embolisation device).

c) Clinicians should submit details of all patients being treated with the Pipeline embolisation device to the UK Neurointerventional Radiology Group audit database, to increase the evidence base and guide future use of this technology.

3. The Pipeline embolisation device is manufactured by Covidien.

4. The cost of the Pipeline embolisation device stated in the sponsor's submission was £10,171.

About the Medical Technologies Evaluation Programme

5. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions.

The independent Medical Technology Advisory Committee (MTAC) has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. In producing medical technology guidance, MTAC looks at whether a device offers benefits to the patient and NHS at a lower cost compared with similar products, or increased benefits for equal cost. The guidance applies to the NHS in England, and is not mandatory.

More information is available at /guidance/mtg7/resources/medical-technologies-evaluation-programme .

About NICE

6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

7. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

8. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

9. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.