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The first draft guidance from the new medical technologies programme at the National Institute for Health and Clinical Excellence (NICE) is issued today for consultation. Positive provisional recommendations are made on the use of the balloon catheter, SeQuent Please, for patients with restenosis following insertion of bare metal coronary artery stents. Restenosis is where the blood vessel becomes blocked again after previous treatment with a stent.

SeQuent Please consists of balloon angioplasty and local delivery of the drug paclitaxel to treat the stenotic lesion. Treatment aims to relieve angina symptoms and reduce the risk of symptom recurrence and the incidence of restenosis. This draft guidance comes from the Evaluation Pathway Programme for Medical Technologies, which will help enable new medical technologies, or important modifications to existing ones, to be used more quickly and consistently in the NHS. This draft guidance was produced by the Medical Technologies Advisory Committee (MTAC).

The draft recommendations on SeQuent Please 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 their clinician wishes to minimise their use of antiplatelet drugs. It should also be considered for use in patients in whom it would be technically difficult to insert more stents. MTAC also recommended further research into longer term outcomes.

MTAC considered that reductions in the number of cases of restenosis requiring medical treatment, readmission and repeat surgery would have long-term cost savings, if these effects were maintained in the long term. MTAC advised that further research to demonstrate long-term outcomes would be useful to confirm this expected benefit.

Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “We’re delighted to open the consultation on the first draft guidance produced by the new Medical Technologies Advisory Committee (MTAC). The balloon stent SeQuent Please is the first topic to be considered by Committee. The positive provisional recommendations advise that the device should be considered for use in patients with in-stent restenosis in specific circumstances. MTAC’s view is that SeQuent Please may benefit patients and the NHS in the long term by reducing the number of cases requiring further treatment for restenosis. We look forward to receiving comments on our provisional recommendations from health professionals, industry and patient groups to help inform the development of this guidance.”

The consultation will run for 4 weeks, ending at 5pm on 2 August 2010. The consultation responses received will be fully considered by MTAC, and final guidance is expected to be published in October 2010.

Notes to Editors

About the guidance

1. The cost models used indicated that the SeQuent Please balloon catheter was associated with a cost saving of £630 per patient compared with standard therapy.

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

About the Evaluation Pathway Programme for Medical Technologies

3. 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.

4. The consultation on the proposed process and methods guides for the Evaluation Pathway Programme for Medical Technologies runs from 18 June to 10 September 2010. View the proposed process and methods guides for the Evaluation Pathway Programme for Medical Technologies.

About NICE

5. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance 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 and procedures within the NHS

clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.