NICE has developed a medtech innovation briefing (MIB) on the Cellvizio confocal endomicroscopy system for characterising pancreatic cysts.
Cellvizio is a confocal laser endomicroscopy (CLE) system with a fibre-optic probe for real-time imaging of tissues. It is designed for use as an adjunct to the standard endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedure, to characterise pancreatic cysts and provide additional information to help guide therapeutic decisions. The evidence summarised in this briefing comes from 2 feasibility and 3 pilot studies with a total of 138 adult patients. The diagnostic accuracy for Cellvizio was reported to be between 71% and 87% in 3 studies compared with histopathology, EUS-FNA or a committee consensus. In 2 studies, images were successfully obtained in all patients. In another study, images were successfully obtained in most (17 of 18) patients. The device was used to identify and validate new diagnostic criteria for pancreatic cyst types in 4 studies. The numbers of safety incidents in 2 Cellvizio studies were higher than reported in a previous EUS-FNA-only study. The main capital component of the Cellvizio system costs £79,000 with installation, commissioning and initial training costs of £2,145. Each fibre-optic miniprobe (AQ-Flex 19) can be used up to 10 times and costs £4,000. All costs are excluding VAT.
Medtech innovation briefings provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
Medtech innovation briefings are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
NICE medtech innovation briefings are commissioned by NHS England and produced in support of Innovation Health and Wealth.