The National Institute for Health and Care Excellence (NICE) today (14 August), opens a consultation on its draft medical technology guidance on a device used in treating bulging blood vessels and tears in the wall of the main artery carrying blood from the heart to the body.

The draft medical technology guidance supports the case for adopting the E-vita open plus for treating complex aneurysms and dissections of the thoracic aorta, in a carefully selected group of people. Some people might normally need a two stage repair operation because of the extent of disease or damage affecting their aorta, but using the device could remove the need for a second procedure and the associated risk of serious complications.

An aneurysm is a bulge in a blood vessel that's caused by a weakness in the blood vessel wall. If an aneurysm ruptures, the resulting haemorrhage can be fatal. Dissections of the thoracic aorta occur when the artery is damaged, and a tear occurs in its weakened wall. Blood then flows in between the layers of the artery wall, and left untreated this could press on other blood vessels or rupture, causing death.

The E-vita open plus is a device consisting of two sections joined together which allows two areas of damaged aorta to be treated in one procedure. Once in place, the blood flows through the device, instead of into the aneurysm or the tear in the wall of the aorta. The device can also replace part of the aorta if it is badly damaged. The blood in the aneurysm or the damaged wall of the aorta eventually forms a clot, posing no further risk.

Because there is no need for a second operation and the risk of complications is reduced, outcomes for patients are improved and there are anticipated savings associated with using the device compared to standard two stage procedures. Savings are generated from around two years after the procedure using E-vita open plus. At 10 years after the procedure estimated savings range from just under £22,000 to around £28,000 per patient compared with current practice.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “In this draft guidance, the independent Medical Technologies Advisory Committee (MTAC) considered that there was evidence to support the use of the E-vita open plus for treating complex aneurysms (bulging blood vessels) and tears in the wall of the aorta. This use was estimated to potentially save the NHS up to £28,000 per patient over 10 years compared to standard management. As a second surgical procedure would be avoided by using the E-vita open plus, this device would benefit the patient as well as the NHS. We welcome comments on the draft guidance as part of the current consultation.”

More information on the medical technology draft guidance consultation for the E-vita open plus is available at MTG16. The consultation closes at 5pm on 12 September 2013.

ENDS

Notes to Editors

About the NICE guidance

1. The draft medical technologies guidance, “E-vita open plus for treating complex aneurysms and dissections of the thoracic aorta”, is available on the NICE website.

2. The E-vita open plus is manufactured by JOTEC GmbH.

3. The potential for savings ranges from £21,847 to £28,158 per patient at 10 years following the procedures, compared with current management for different clinical scenarios.

4. Around 50 to 100 people each year may be suitable for treatment with E-vita open plus.

5. The cost of the E-vita open plus stated in the sponsor's submission was £10,500 excluding VAT.

About the Medical Technologies Evaluation Programme

6. 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 has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available on the NICE website.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

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