NICE guidance supports coronary drug-eluting balloon for in-stent restenosis


The UK National Institute for Health and Clinical Excellence (NICE) issued its first medical technology guidance which supports the use of a device used in coronary artery intervention on 1 December 2010. The positive final guidance confirms the case for adopting the SeQuent Please drug-eluting balloon (B.Braun) for patients with restenosis following insertion of bare metal coronary artery stents.

SeQuent Please balloon catheter consists of balloon angioplasty 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 is used. It should also be considered as an option for use in patients in whom it is not 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, SeQuent Please 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.


Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “We are delighted to publish this first medical technology guidance – it is an important milestone both for NICE and the organisations we have 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