4.1 No secondary treatments were required at 1-year follow-up among patients in the PUFS study (FDA 2011). Need for retreatment was not reported in the PITA study (Nelson et al. 2011). Need for retreatment was not reported in the other 14 studies included in the external assessment centre's assessment report.
4.2 The committee noted that little evidence was available on the need for retreatment following treatment with Pipeline.
4.3 The committee recognised that there are a small number of patients for whom Pipeline offers the only possible means of treatment (an estimated 60 patients per year in the UK). For these patients the potential benefits offered by Pipeline are important, because they are at high risk of aneurysm rupture and because their intracranial aneurysms are unsuitable for other treatments.