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NICE's medical technologies programme issues first draft guidance

Article: 804875 deviceThe first piece of guidance has been published from NICE's new medical technologies programme, set up to help the NHS adopt efficient and cost effective medical devices and diagnostics more rapidly and consistently.

The draft guidance recommends the use of a balloon catheter, SeQuent Please, for patients who have suffered restenosis, a condition where the blood vessels become blocked again following a previous treatment with a stent.

The Evaluation Pathway Programme for Medical Technologies was established in November 2009 to focus specifically on the evaluation of innovative medical technologies. Its purpose is to produce guidance on the use of devices and diagnostics to speed up the introduction into the health service of those products offering significant benefits, or helping technologies to be investigated more thoroughly in research.

The types of products that are assessed under the new programme 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.

An independent group of experts, the Medical Technologies Advisory Committee (MTAC), is responsible for deciding which medical technologies should be selected for evaluation, as well as developing the guidance itself.

This Committee is made up of 25 members, including representatives from industry, lay people, health economists, medical scientists and a range of others so that there is a diverse input into the decision making.

Under this latest draft guidance, the Committee recommends that the SeQuent Please balloon catheter be used to relieve angina symptoms and reduce the risk of restenosis following the insertion of bare metal coronary artery stents.

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: “The drug coated balloon 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 the 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 look forward to receiving comments on our provisional recommendations from health professionals, industry and patient groups to help inform the development of this guidance.”

NICE is keen for more manufacturers to notify the Institute of devices or diagnostics for consideration by the Evaluation Pathway Programme, and for comments on the proposed process and methods guides for the Evaluation Pathway Programme. A consultation is currently running until 10 September 2010.

15 July 2010

This page was last updated: 30 July 2010

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.