NICE has published a medtech innovation briefing (MIB) on the Archimedes system for lung biopsy.
MIBs are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The briefing provides a description of the technology, how it’s used, and its potential role in the treatment pathway, including a review of relevant published evidence and the likely costs of using the technology.
Archimedes uses pattern recognition software to reconstruct CT scans and create full 3D images. It is intended to be an alternative to CT‑guided transthoracic biopsy for definitive diagnosis of lung lesions in people with suspicious nodules.
The main evidence summarised in the briefing comes from four observational studies including a total of 59 people with lung lesions in secondary care. The evidence showed that Archimedes allows access to lesions anywhere in the lung, with a diagnostic yield of 75%-85%, and the risks of major complications such as pneumothorax are low.
However, no comparators were included in the studies and none were carried out in UK. Furthermore, sample sizes were small, ranging from six to 25 people.
The cost of the Archimedes System is £240,000 (exclusive of VAT). The resource impact would be greater than a CT‑guided transthoracic biopsy, the average cost of which is £1357. Some of the extra costs may be offset because of fewer complications and a shorter inpatient stay, however, there is limited evidence to support these claims.
All three experts who contributed to the MIB concluded that Archimedes would be used as an add-on to current CT‑guided biopsy, and one noted that patients still need an additional CT scan to plan the procedure. None of the experts was aware of any safety issues but pointed out that data collection on the safety of the technology is ongoing. Two experts felt more studies were needed to improve the current evidence base, especially a study comparing the accuracy of the technology with that of CT‑guided biopsy or other bronchoscopy in the NHS.