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The National Institute for Health and Clinical Excellence (NICE) today issues its first medical technology guidance, which supports the use of a device used in coronary artery surgery. The positive final guidance confirms the case for adopting SeQuent Please balloon catheter for patients with restenosis following insertion of bare metal coronary artery stents. A stent is a small mesh tube that is used to prop open or treat narrowed or weakened blood vessels. Restenosis is where the blood vessel becomes blocked again after previous treatment with a stent.

SeQuent Please balloon catheter consists of balloon angioplasty (a surgical procedure to widen blocked or narrowed coronary arteries) and local delivery of the drug paclitaxel to treat the part of the artery affected. Treatment aims to relieve angina symptoms, reduce the risk of symptoms recurring and the incidence of restenosis.

The recommendations on SeQuent Please balloon catheter include that it should be considered for use in patients with in-stent restenosis in bare metal coronary artery stents, and in patients with other types of stent where there are clinical reasons to minimise how long clopidogrel treatment (to reduce blood clotting) is used. It should also be considered as an option for use in patients in whom it isn't technically possible to insert further stents. The guidance also recommends further research in a UK setting comparing long-term outcomes of patients treated with SeQuent Please balloon catheter to those treated with other types of drug-eluting balloon catheter and stent.

This first medical technology guidance was produced by the Medical Technologies Advisory Committee (MTAC), which is part of the Evaluation Pathway Programme for Medical Technologies. This new programme will help enable new medical technologies, or innovative modifications to existing ones, to be used more quickly and consistently in the NHS across England. In particular, 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. After the first year of use, SeQuentPlease balloon catheter is associated with an annual estimated cost saving to the NHS of nearly £485,000, compared with standard therapy. MTAC considered that reductions in the number of cases of restenosis requiring medical treatment, readmission and repeat surgery would have future cost savings, if these effects were maintained in the long term.

Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “We are delighted to publish this first medical technology guidance - it's an important milestone both for NICE and the organisations we've worked with closely in establishing the new program to evaluate medical technologies. This positive guidance advises the NHS that SeQuent Please balloon catheter should be considered for use in patients with in-stent restenosis in specific circumstances. The evidence considered indicates that SeQuent Please balloon catheter may benefit patients and the NHS in the long term by reducing the number of cases requiring further treatment for restenosis. We hope that the NHS will find that our new pieces of medical technology guidance will help provide clarity on innovative devices that provide good-value improvements to patient care.”

More information on the new medical technology guidance is available at www.nice.org.uk/guidance/MTG1.

Notes to Editors

About the guidance

1. The cost models used indicated that SeQuent Please balloon catheter is associated with an estimated annual cost saving of £484,800 to the NHS after the first year of use, compared with paclitaxel eluting stent.

2. SeQuent Please balloon catheter is manufactured by B.Braun.

3. The cost of a SeQuent Please balloon catheter is approximately £650 to £950; costs may vary because of differences in purchasing contracts.

About the Evaluation Pathway Programme for Medical Technologies

4. Established by NICE in 2009, the focus of this new 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 at http://www.nice.org.uk/MT.

About NICE

5. The National Institute for Health and Clinical 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

6. 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.

7. 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

8. 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.