superDimension Navigation System to help diagnostic sampling of peripheral lung lesions

The technology described in this briefing is the superDimension Navigation System. It is used to guide endoscopic tools or catheters during biopsy of mediastinal and peripheral lung lesions.

The innovative aspects are access and biopsy of peripheral lung lesions without the need for pleural puncture. The technique involves real-time navigation into the peripheral lung, without needing ionising radiation.

The intended place in therapy would be as an alternative technique for definitive diagnosis of peripheral lung lesions in people for whom percutaneous or surgical approaches are thought to be too high risk.

The main points from the evidence summarised in this briefing are from 7 studies including a total of 8,359 patients in secondary care. Comparative evidence shows that electromagnetic navigation bronchoscopy-guided biopsy is less effective in terms of diagnostic yield (proportion of definitive diagnoses), but with lower pneumothorax rates than CT-guided trans-thoracic needle aspiration in patients with peripheral lung and mediastinal lesions.

Key uncertainties around the evidence are the different definitions of diagnostic yield used in the meta-analyses of primary studies and no studies were identified in a UK setting.

The cost of using the superDimension Navigation System is estimated by the company to be £1,942 to £2,331 per procedure. The resource impact would be greater than standard care, where the estimated average cost of a CT-guided trans-thoracic biopsy procedure is £1,357.