The National Institute for Health and Clinical Excellence (NICE) is producing guidance on using the Pipeline embolisation device for the treatment of complex intracranial aneurysms in the NHS in England. The Medical Technologies Advisory Committee has considered the evidence submitted and the views of expert advisers.

This document has been prepared for public consultation. It summarises the evidence and views that have been considered, and sets out the draft recommendations made by the Committee. NICE invites comments from the public. This document should be read along with the evidence base (the assessment report and assessment report summary), which is available from www.nice.org.uk/mt.

The Advisory Committee is interested in receiving comments on the following:

• Has all of the relevant evidence been taken into account?
• Are the summaries of clinical effectiveness and resource savings reasonable interpretations of the evidence?
• Are the provisional recommendations sound, and a suitable basis for guidance to the NHS?
• Are there any equality issues that need special consideration and are not covered in the medical technologies consultation document?

Note that this document is not NICE's final guidance on the Pipeline embolisation device for the treatment of complex intracranial aneurysms. The recommendations in section 1 may change after consultation. After consultation the Committee will meet again to consider the evidence, this document and comments from public consultation. After considering these comments, the Committee will prepare its final recommendations which will be the basis for NICE’s guidance on the use of the technology in the NHS in England.

For further details, see the ‘Medical Technology Evaluation Programme process guide’ (available at www.nice.org.uk/mt).

Key dates:

• Closing time and date for comments: 5:00pm 18 December 2011
• Second Medical Technologies Advisory Committee meeting: Thursday 19 January 2012

NICE medical technologies guidance addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.

1 Provisional recommendations

1.1 The case for adopting the Pipeline embolisation device in the NHS is supported by the current evidence when it is used in patients with giant or complex intracranial aneurysms which are unsuitable for surgery, which are being considered for stenting and where large numbers of coils are needed during stent-assisted coiling. 

1.2 The Pipeline embolisation device is estimated to be cost saving when compared with stent-assisted coiling, in patients with giant or complex intracranial aneurysms when the number of Pipeline embolisation devices inserted does not exceed two and when treatment would otherwise require the use of 29 or more coils combined with one stent for stent-assisted coiling. If two Pipeline embolisation devices are used the total procedure cost is estimated as £30,354 compared with £30,775 for the use of 29 coils for stent assisted coiling (a saving of £421 using the Pipeline embolisation device).

1.3 Clinicians should submit details of all patients being treated with the Pipeline embolisation device to the UK Neurointerventional Radiology Group audit database, to increase the evidence base and guide future use of this technology.

2 The technology

Description of the technology

2.1 The Pipeline embolisation device (Covidien) is a self-expanding blood flow diverter that is placed across the neck of an intracranial aneurysm. While blood flow through the parent vessel is maintained via the device, flow within the aneurysm sac is disrupted, leading to stagnation and eventual thrombosis formation. The Pipeline embolisation device provides a scaffold for endothelial growth leading to the formation of a biological seal and exclusion of the aneurysm from the circulation.

2.2 The Pipeline embolisation device is a braided, cobalt chromium and platinum stent-like device which is loaded into and delivered via a microcatheter. It is manufactured in lengths of 10–35 mm and is available in different diameters from 2.5 to 5 mm (in 0.25-mm increments). Multiple devices can be used within each other and/or in sequence to increase the overall length of the construct or to increase the metal surface coverage within an aneurysm.

2.3 The Pipeline embolisation device is indicated for use in patients with unruptured, complex intracranial aneurysms, specifically large and giant, wide-necked and fusiform aneurysms. This is the group of patients covered by this guidance. It may also be used in patients whose aneurysms are unsuitable for standard coiling and/or stenting and for neurosurgical treatment; and in patients for whom previous coiling/clipping procedures have failed.

2.4 The cost of the Pipeline embolisation device stated in the sponsor’s submission was £10,171.

2.5 The claimed benefits of the Pipeline embolisation device in the case for adoption presented by the sponsor are:

• A higher rate of complete, permanent occlusion of large/giant intracranial aneurysms compared with coiling and stent-assisted coiling, leading to reduced rates of retreatment and a decreased risk of haemorrhage.
• Increased accessibility to treatment for patients with complex intracranial aneurysms. The Pipeline embolisation device offers a new option for treating patients with complex intracranial aneurysms which are not suitable for stent-assisted coiling or surgery, or patients for whom previous interventions have failed.
• Patients may experience a resolution of neurological symptoms as a result of pressure on surrounding areas of the brain caused by the mass effect of aneurysms.
• Increased long-term vessel patency, preserving blood flow to distal tissues supplied by the aneurysmal artery.
• The high rate of complete, permanent occlusion of the target aneurysm with the Pipeline embolisation device may lead to a reduced need for retreatment and an overall decrease in use of NHS resources.

Current management

2.6 Current options for managing complex intracranial aneurysms include coiling, often with concomitant use of stent placement (stent-assisted coiling), neurosurgical clipping requiring craniotomy (with or without bypass procedures), parent vessel occlusion (by open neurosurgery or by endovascular means) and conservative management.

3 Clinical evidence

Summary of clinical evidence

3.1 Full details of all clinical outcomes considered by the Committee are available in the assessment report overview at mtg10.

3.2 The key clinical outcomes for the Pipeline embolisation device presented in the decision problem are:

• successful device deployment
• successful occlusion of the aneurysm, with or without preservation of flow through the parent vessel
• size of the aneurysm and its contained thrombus mass
• resolution of symptoms (including headache, diplopia, nystagmus or other neurological dysfunction), relief of pain and quality of life outcomes
• resource use outcomes (for example, re-admission rates, repeat interventions and duration of hospital stay)
• stroke related to device insertion (any cause, but particularly due to vessel occlusion or bleeding)
• delayed parent vessel occlusion
• subarachnoid haemorrhage and/or other major bleeding events needing admission to hospital
• neurovascular death
• device-related adverse events.

3.3 The sponsor identified 13 studies relevant to the scope, but because it judged the quality of many of these to be poor and because of duplication in patient reporting, the sponsor’s submission presented detailed findings on a total of 139 patients from two trials, with a maximum follow-up of 2 years. The trials were Pipeline for Intracranial Treatment of Aneurysms (PITA) and Pipeline for Uncoilable or Failed aneurysms (PUFS). 

3.4 Nelson et al. (2011) reported outcomes up to 2 years for the PITA study: a prospective, multicentre single-arm feasibility study of 31 patients with 31 intracranial aneurysms that were either wide necked (neck ≥ 4 mm or dome/neck ratio < 2) or in which previous treatment had failed.

3.5 A report to the FDA by the sponsor (FDA 2011) described the clinical evidence at 1 year from the PUFS study: an ongoing prospective, multicentre, single-arm study of 107 patients with 110 intracranial aneurysms that were wide necked (> 4 mm or no discernable neck and a size > 10 mm), large or giant (2.5–5 mm).

3.6 In its scrutiny of the sponsor’s submission, the External Assessment Centre found three case reports and one conference abstract of 96 patients in addition to the 13 studies identified by the sponsor. It excluded one of the studies identified by the sponsor (Matouk et al. 2010) because it was outside the scope. The External Assessment Centre therefore included a total of 16 studies with 379 patients in its assessment report.  

3.7 Across 13 studies with a total of 237 patients (239 complex intracranial aneurysms), successful device placement was reported in 50–100% of patients. In eight of the 13 studies, successful device placement was reported in all patients (25 in total). (Fiorella et al. 2008, 2009a, 2009b, 2010; Hartmann et al. 2010; Kilsch et al. 2011; Phillips et al. 2010; Sararols et al. 2011).

3.8 Nelson et al. (2011) reported clinical procedure success (defined as successful placement of the device without death or ipsilateral stroke) in 94% (29/31) of patients: the two failures were because of stroke. For patients in the PUFS study, the primary effectiveness endpoint was complete occlusion of the aneurysm and absence of parent vessel stenosis greater than 50% at 180 days. The probability of exceeding a pre-determined ‘success threshold’ of 50% was statistically significant (p < 0.0001) (FDA, 2011).

3.9 Major ipsilateral stroke was reported in 6% (6/107) of patients at 180 days in the PUFS study (FDA 2011) and in 7% (2/31) of patients within 30 days in the PITA study (Nelson et al. 2011). Five other studies including a total of 58 patients (68 complex intracranial aneurysms) reported a stroke rate of 0% at follow-up ranging from 10 weeks to more than 52 weeks (Fiorella et al. 2009a, 2009b; Lylyk et al. 2009a; Klisch et al. 2011; Sararols et al. 2011).

3.10 In the PUFS study, 3 of the 6 patients who had a major ipsilateral stroke died (timing of events not reported). Nelson et al. (2011) reported no deaths in the PITA study.

3.11 Nelson et al. (2011) reported complete occlusion of the target aneurysm in 93% (28/30) of patients at 180 days (95% confidence interval [CI] 77.9 to 99.2%); it was not possible to assess occlusion in 1 patient who had the Pipeline embolisation device surgically removed and the parent vessel ligated. All patients who had complete occlusion at 180 days also had complete occlusion at 2 years as assessed by either catheter angiography or MRI.

3.12 Complete occlusion without major stenosis was reported in 74% (78/106) of aneurysms at 180 days and 71% (75/106) of aneurysms at 1-year angiography (FDA 2011). Eight studies with a total of 131 patients all reported occlusion rates of 100% in patients assessed at follow-up ranging from 3 to 30 months (Fiorella et al. 2008, 2009a, 2009b,. 2010; Klisch et al. 2011; Phillips et al. 2010; Sararols et al. 2011; Szikora et al. 2010b). Occlusion rates of 93%, 89% and 69% were reported by Lylyk et al. (2009a), Szikora et al. (2010a) and O'Kelly et al. (2011) respectively (absolute figures not reported).

3.13 Nelson et al. 2011 reported that 10% (3/31, one of whom had previously had a stroke) showed improvement in intracranial aneurysm-related symptoms at 30 days. There was no deterioration in neurological status at 30 days in the 28 patients free of stroke. The FDA report (2011) described Rankin scoring (a general measure of neurological function) for 101 patients. The scores improved from baseline in 20% (21/101) of patients, remained unchanged in 65% (70/101) and deteriorated in 9% (10/101) at 180 days follow-up. There was an improvement in visual field sensitivity (not otherwise described) from baseline in 19% (19/101) of patients, no change in 65% (65/101) of patients and deterioration in eye function in 5% (5/101) of patients at follow-up of 180 days (FDA 2011). Three case reports described complete resolution of symptoms at follow-up ranging from 10 to 26 weeks (Fiorella et al. 2009a, 2009b; Sararols et al. 2011). Szikora et al. (2010b) reported resolution of symptoms in 61% of patients at a mean follow-up of 26 weeks.

3.14 Studies of 96, 18, 8 and 5 patients reported postoperative subarachnoid haemorrhage in 1%, 5%, 13% and 20% of patients respectively (absolute figures and follow-up not reported) (Hampton et al. 2011; Hartmann et al. 2010; O'Kelly et al. 2011, Szikora et al. 2010b).

Committee considerations

3.15 The Committee was advised by the expert advisers that the Pipeline embolisation device is currently considered in some specialist units for patients who have symptoms caused by the mass effect of aneurysms, or a high risk of future bleeding, who are considered fit for general anaesthesia and who have an average life expectancy of at least 1 year.

3.16 The Committee noted that the Pipeline embolisation device may be the only possible intervention for some patients who have symptoms caused by the mass effect of aneurysms, or a high risk of future bleeding, whose aneurysms are unsuitable for either stent- assisted coiling or surgical treatment and for whom parent vessel occlusion would result in stroke or death.

3.17 The Committee considered that data from the studies described above provided evidence for the efficacy of the Pipeline embolisation device in most patients. In the context of the high risks posed to patients by untreated complex aneurysms the safety profile was judged to be acceptable.

3.18 The Committee noted that the effect of the device on symptoms or on the risk of bleeding is subject to some delay.  It was advised by the sponsor that this is because the Pipeline embolisation device does not immediately decrease the pressure on the aneurysm, and that this had been demonstrated on angiographic imaging.

3.19 The Committee recognised that patient selection for treatment either by the Pipeline embolisation device or by comparator interventions is complex, and needs to be carried out by an experienced multidisciplinary team.

3.20 The Committee noted that most of the clinical evidence came from the United States, where patient selection for different types of endovascular interventions may differ from the UK, in terms of the treatments selected for intracranial aneurysms based on their size and shape.

3.21 The Committee noted that the clinical evidence comparing the efficacy of the Pipeline embolisation device with other interventions was very limited. This made evaluation difficult. The Committee recognised the difficulties in conducting comparative studies, particularly randomised controlled trials, for large and complex intracranial aneurysms.

3.22 The Committee noted that both new studies and an extension of the PUFS study, involving 3-year outcomes, are in progress.

3.23 In addition to the ongoing studies, the Committee considered that data collection using a register would also be an important practical way of developing evidence to guide future practice.

4 NHS considerations

System impact

4.1 No secondary treatments were required at 1-year follow-up among patients in the FDA report (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 report.

Committee considerations

4.2 The Committee noted that little evidence was available on the need for retreatment following treatment with the Pipeline embolisation device.

4.3 The Committee recognised that there are a small number of patients for whom the Pipeline embolisation device offers the only possible means of treatment (an estimated 60 patients per year in the UK). However, for these patients the potential benefits offered by the Pipeline embolisation device are important, because they are at high risk and because the intracranial aneurysms are unsuitable for other treatments.

5 Cost considerations

Cost evidence

5.1 The sponsor submitted a new cost analysis for the Pipeline embolisation device for the treatment of complex intracranial aneurysms. Full details of all cost evidence and modelling considered by the Committee are available in the assessment report overview (mtg10).

5.2 The cost analysis submitted by the sponsor combined a decision tree with Markov techniques to assess the costs and consequences associated with the Pipeline embolisation device against five comparator interventions: stent-assisted coiling, neurosurgical clipping, endovascular parent vessel occlusion, neurosurgical parent vessel occlusion and conservative management. The patient population included those with unruptured large or giant intracranial aneurysms as outlined in the scope, but did not include fusiform or wide-necked aneurysms

5.3 The decision-tree structure separated patients who had survived initial treatment, based on a mortality rate for the procedure, into one of three occlusion categories (complete occlusion, residual neck and residual aneurysm). For each occlusion category, patients were tracked through five possible health states: 'no complications', 'new non-fatal rupture', 'post rupture', 'fatal rupture' and 'dead (all cause)’. It was assumed that transition probabilities for the health states would be constant over time. The time horizon of the base-case analysis was 10 years.

5.4 An NHS and Personal Social Services perspective was used. The cost analysis included the costs associated with the duration of the procedure, staff time (surgeon, radiologist, nurse, anaesthetist), hospital costs (neurology operating or neurosurgical operating room, and recovery ward), imaging (angiography, fluoroscopy or MRI), consumables, drugs; and for conservative management only, long-term monitoring with annual MRI. The cost associated with stroke was assumed to be representative of the cost of rupture. Costs applied to each type of retreatment were assumed to be the same as the full cost if that treatment had been used initially.

5.5 The costs and consequences associated with adverse events were not included in the base-case analysis because the sponsor considered there to be insufficient reliable data for each treatment group. However, the sponsor did include costs associated with mortality at 31 days, rupture and retreatment.

5.6 In the base case the number of Pipeline embolisation devices used was 1.46, based on data submitted to the sponsor from use of the device in UK hospitals up to August 2011. The number of coils used in the base case was 40 and was derived from an estimate in an editorial review by Wehman in 2006. It was assumed that one stent would be needed for each stent-assisted coiling intervention.

5.7 The base case presented the total procedure costs over the 10-year time horizon associated with the Pipeline embolisation device as £24,341. For the comparators, the total procedure costs were £37,451 for stent-assisted coiling, £11,658 for neurosurgical clipping, £16,893 for endovascular parent vessel occlusion, £11,654 for neurosurgical parent vessel occlusion and £10,352 for conservative management. The only intervention against which the Pipeline embolisation device was shown to be cost saving was stent-assisted coiling, with a cost saving of £13,110 per patient. 

5.8 Two scenario analyses were presented. One included costs associated with the adverse events of subarachnoid haemorrhage related to the aneurysm, thromboembolic stroke and intracranial haemorrhagic stroke remote from the aneurysm using data from the PUFS study and data from Darsault et al (2001) for the comparators. The other scenario analysis restricted the time horizon to 6 months (short-term). Conservative management was excluded from the short-term scenario because it does not have a 'peri-procedural' mortality rate.

5.9 In both scenario analyses the Pipeline embolisation device was shown to be cost saving when compared only with stent-assisted coiling. When costs associated with adverse events were included in the model, the Pipeline embolisation device remained a cost-saving intervention compared with stent-assisted coiling, with an associated saving of £13,327. When outcomes were restricted to the short term (6 months), the Pipeline embolisation device remained cost saving compared with stent-assisted coiling (£10,316).

5.10 Sensitivity analyses carried out by the sponsor showed that the main factors influencing the cost analysis were the number and cost of consumables, in particular the numbers of Pipeline embolisation devices and endovascular coils. The sponsor carried out sensitivity analysis for the use of 1–3 Pipeline embolisation devices and separately for 5–100 coils.

5.11 The number of Pipeline embolisation devices used in the base case was 1.46 per patient. On receipt of further UK hospital data, the sponsor submitted a revised number of 1.658 in October 2011. The External Assessment Centre reviewed the published literature and calculated a mean usage of 2.41 Pipeline embolisation devices per patient, which it considered to be a more appropriate value for the model.

5.12 The External Assessment Centre received opinions from three Expert Advisers whose consensus was that 40 coils used in the base case may have been an overestimate. In the absence of a single more reliable estimate, the External Assessment Centre used a pragmatic value of 25 coils in the model, based on Expert Adviser opinion.. The number of stents used in the base case for stent-assisted coiling was one. It was assumed in the sensitivity analysis that only one stent was used, regardless of the number of coils.

5.13 When 1.658 Pipeline embolisation devices were used, the Pipeline embolisation device was more costly compared to stent-assisted coiling if 22 coils were used (an estimated cost increase of £19), but cost saving when 23 coils were used. The cost saving when using 1.658 Pipeline embolisation devices compared with 23 coils was estimated to be £588 (£26,546 and £27,134 respectively). When two Pipeline embolisation devices were used, the Pipeline embolisation device was more costly by an estimated £185 when 28 coils were used but less costly when 29 coils were used. The cost saving when using two Pipeline embolisation devices compared with 29 coils was estimated to be £421 (£30,354 and £30,775 respectively).

Committee considerations

5.14 The Committee considered the cost consequences of using the Pipeline embolisation device against five comparators – stent-assisted coiling, neurosurgical clipping, endovascular parent vessel occlusion, neurosurgical parent vessel occlusion and conservative management.  

5.15 The Committee noted that, in UK clinical practice, patients who might currently be considered for the Pipeline embolisation device would be those for whom surgery would not be possible and for whom stent-assisted coiling would be the only other potential intervention. It therefore considered that comparison of costs with those for stent-assisted coiling was of particular relevance. The Committee noted that for this cost comparison, the main drivers of cost were the numbers of Pipeline embolisation devices used and the numbers of coils used. It received differing advice about the number of Pipeline embolisation devices and coils normally needed to treat each patient, but expert advice and data from the sponsor both suggested that the use of two Pipeline embolisation devices was a reasonable estimate for practice in the UK. 

5.16 There was more uncertainty about the number of coils likely to be used during stent-assisted coiling. The Committee was advised that 40 coils was probably an overestimate of the number needed for most complex aneurysms and there were suggestions that about 25 coils might be more typical of the number required for aneurysms which invite consideration of treatment using the Pipeline embolisation device.

5.17 With these issues in mind, the Committee considered a graph showing the costs of the Pipeline embolisation device and of stent- assisted coiling using different numbers of Pipeline embolisation devices and coils. This indicated that the total cost of treatment using two Pipeline embolisation devices was greater than that of stent-assisted coiling (using one stent) if 28 coils or less were used, but the Pipeline embolisation device was less costly if 29 or more coils were needed. The cost saving of the Pipeline embolisation device compared with 29 coils was estimated to be £421 (total costs of £30,354 and £30,775 respectively). If 40 coils were needed the total cost would be £30,354 for the Pipeline embolisation device and £37,451 for stent-assisted coiling – a saving of £7,098.

5.18 The Committee noted that using two Pipeline embolisation devices would incur a higher total treatment cost than neurosurgical clipping, endovascular parent vessel occlusion, neurosurgical parent vessel occlusion or conservative management, for patients in whom those other options were feasible.

6 Conclusions

6.1 The Committee concluded that current evidence supports the case for adoption of the Pipeline embolisation device when it is used in highly selected patients with giant or complex intracranial aneurysms which would require 29 or more coils during stent-assisted coiling and which are unsuitable for neurosurgical treatment. For these patients use of the Pipeline embolisation device appears efficacious and is less costly than stent-assisted coiling.

6.2 The Committee noted that the Pipeline embolisation device may be the only feasible intervention for some patients whose giant or complex intracranial aneurysms are unsuitable in size or shape for stent-assisted coiling or surgery, and for whom parent vessel occlusion would result in stroke or death. This group of patients are outside the scope of the recommendations.

7 Implementation

7.1 NICE is developing tools to help organisations put this guidance into practice (listed below). These will be available on our website at final publication (www.nice.org.uk/guidance/MTGXXX).

8 Related NICE guidance

Published

• Coil embolisation of ruptured intracranial aneurysms. NICE interventional procedure guidance 106 (2005). Available from www.nice.org.uk/guidance/IPG106
• Coil embolisation of unruptured intracranial aneurysms. NICE interventional procedure guidance 105 (2005). Available from www.nice.org.uk/guidance/IPG105
• Supraorbital minicraniotomy for intracranial aneurysm. NICE interventional procedure guidance 84 (2004). Available from www.nice.org.uk/guidance/IPG84
• High-flow interposition extracranial to intracranial bypass. NICE interventional procedure guidance 73 (2004). Available from www.nice.org.uk/guidance/IPG73 

Bruce Campbell
Chairman, Medical Technologies Advisory Committee
November 2011

Appendix A. Committee members and NICE lead team

A Medical Technologies Advisory Committee members

The Medical Technologies Advisory Committee is a standing advisory committee of NICE. A list of the Committee members who took part in the discussions for this guidance appears below.

Committee members are asked to declare any interests in the technology to be evaluated. If it is considered there is a conflict of interest, the member is excluded from participating further in that evaluation.

The minutes of each Medical Technologies Advisory Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website.

Professor Bruce Campbell (Chair)
Consultant Vascular Surgeon, Exeter

Dr Peter Groves (Vice Chair)
Consultant Cardiologist, Cardiff and Vale NHS Trust

Dr Dilly Anumba
Senior Clinical Lecturer/Honorary Consultant Obstetrician and Gynaecologist, University of Sheffield

Ms Susan Bennett
Lay member

Professor Bipin Bhakta
Charterhouse Professor in Rehabilitation Medicine and NHS Consultant Physician, University of Leeds

Dr Keith Blanshard
Consultant Radiologist, Leicester Royal Infirmary

Dr Martyn Bracewell
Senior Lecturer in Neurology and Neuroscience, Bangor University

Dr Daniel Clark
Head of Clinical Engineering, Nottingham University Hospitals NHS Trust

Professor Karl Claxton
Professor of Economics, University of York

Mrs Gail Coster
Radiography Manager, Strategy, Planning and Governance, Yorkshire NHS Trust

Dr Craig Dobson
General Practitioner and Senior Lecturer in Medical Education and General Practice, Hull York Medical School

Dr Alex Faulkner
Senior Research Fellow, Centre for Biomedicine & Society, King's College London

Professor Tony Freemont
Professor of Osteoarticular Pathology, University of Manchester

Professor Peter Gaines
Consultant Interventional Radiologist, Sheffield, Vascular Institute and Sheffield Hallam University

Mr Harry Golby
Head of Commissioning, Acute, Access and Diagnostics, Salford NHS

Mr Matthew Hill
Lay member

Dr Paul Knox
Reader in Vision Science, University of Liverpool

Ms Catherine Leonard
Reimbursement Manager, Medtronic UK

Dr Susanne Ludgate
Clinical Director, Devices Medicines and Healthcare Products Regulatory Agency

Professor Christopher McCabe
Professor of Health Economics, Institute of Health Sciences, University of Leeds

Mrs Jacqui Nettleton
Programme Director, Long Term Conditions, West Sussex PCT

Professor Sharon Peacock
Professor of Clinical Microbiology, University of Cambridge

Dr Allan Swift
Director of Quality and Regulatory Affairs, Gen-Probe Life Sciences

Professor Stephen Westaby
Consultant Cardiac Surgeon, John Radcliffe Hospital, Oxford

Dr Janelle York
Lecturer and Researcher in Nursing, University of Salford

B NICE lead team

Each medical technology assessment is assigned a lead team of a NICE technical analyst and technical adviser, an expert adviser, a technical expert, a patient expert, a non-expert member of the Medical Technologies Advisory Committee and a representative of the External Assessment Centre.

Suzi Peden
Technical Analyst

Lizzy Latimer
Technical Adviser

Dr. Tony Goddard
Lead Expert Adviser

Dr. Phil White
Lead Expert Adviser

Dr Dilly Anumba
Non-Expert MTAC Member

Grace Carolan-Rees and Kathleen Withers
External Assessment Centre Representatives

Appendix B: Sources of evidence considered by the Committee

A The External Assessment Centre report for this assessment was prepared by CEDAR:

• Withers K, Carolan-Rees D, Dale M, et al. External Assessment Centre report: Pipeline embolisation device for the treatment of complex intracranial aneurysms. September 2011.

B Submissions from the following sponsor:

• Covidien

The following individuals gave their expert personal view on the Pipeline embolisation device by providing their expert comments on the draft scope and assessment report.

• Dr Tony Goddard, Consultant Diagnostic and Interventional Radiologist, British Society of Neuroradiologists
• Dr Rob Lenthall, Consultant Neuroradiologist, British Society of Neuroradiologists
• Dr Andy Molyneux, Consultant Neuroradiologist, British Society of Neuroradiologists
• Dr Phil White, Consultant Neuroradiologist, British Society of Neuroradiologists

C The following individuals gave their expert personal view on the Pipeline embolisation device in writing by completing a patient questionnaire or expert adviser questionnaire provided to the Committee.

• Dr Tony Goddard, Consultant Diagnostic and Interventional Radiologist, British Society of Neuroradiologists
• Dr Rob Lenthall, Consultant Neuroradiologist, British Society of Neuroradiologists
• Dr Andy Molyneux, Consultant Neuroradiologist, British Society of Neuroradiologists
• Dr Phil White, Consultant Neuroradiologist, British Society of Neuroradiologists