Advice
The technology
The technology
The Archimedes System (Broncus Medical) is an image-guided navigation system that comprises a workstation, software and optional guided sampling kit. Its purpose is to access tissue samples for biopsies of lung lesions in people with suspected lung cancer. This technology is also known as virtual navigation bronchoscopy. The system integrates bronchoscopic images, CT data and fused fluoroscopic images to provide a reconstructed real-time airway.
The system generates a 3D image during the procedure to access nodules anywhere in the lung. The bronchoscope enters the lungs through the central airways. The system creates a tunnelled path through the lung parenchyma, avoiding blood vessels, directly to the peripheral lesion, which can be sampled or treated.
Archimedes also uses the patient's high-resolution CT to create a virtual representation of their airway. This enables the healthcare professional to select the nodule of interest and see a navigation route to it. The system shows the full vascularisation of the lung so that the healthcare professional knows if they are taking the sample safely without puncturing the pleura.
The system is not intended for use in children. It may not be suitable for pregnant people, people with pacemakers or any metal implants because of the use of fluoroscopy.
Innovations
Archimedes uses pattern recognition software to reconstruct CT scans, and create full 3D images of the airway. The company notes that a potential advantage is that, unlike other technologies that access the airway through bronchioles or percutaneously to reach peripheral lesions, Archimedes can reach them through the parenchyma with fused fluoroscopy. The system can be linked up to a C‑arm (an imaging scanner intensifier) to provide a fused fluoroscopy image of the nodule, so that difficult-to-reach nodules can be accessed. The company claims that the fused fluoroscopy software is unique to Archimedes. The system can also show images of the full lung vascularisation, which is not available through other navigation systems.
Current care pathway
People with known or suspected lung cancer should be offered a contrast-enhanced chest CT scan to diagnosis and stage the disease. They should also be offered endobronchial ultrasound-guided transbronchial needle aspiration (EBUS‑TBNA) for biopsy of paratracheal and peri-bronchial intra-parenchymal lung lesions. When taking samples, the healthcare professional should ensure they are adequate (without unacceptable risk to the person) to permit pathological diagnosis, including tumour subtyping and assessment of predictive markers.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
Archimedes is intended to help tissue sampling during biopsies of lung lesions in people with suspected lung cancer by allowing healthcare professionals to visualise and navigate to the lesion.
The system would most likely be used by respiratory physicians or thoracic surgeons in secondary and tertiary care in the NHS.
Costs
Technology costs
The Archimedes System costs £240,000 (excluding VAT). There is a 1‑year warranty. A service contract costs £23,000 and covers repairs, site visits by an engineer and maintenance checks. If a service contract is not agreed these services have to be paid for individually.
An access kit for bronchial trans-parenchymal nodule access (BTPNA) costs an extra £1,200 (excluding VAT) per procedure. The kit consists of a FleXNeedle, Dilation Balloon and BTPNA catheter.
Costs of standard care
CT‑guided trans-thoracic needle biopsy is the main alternative in the NHS and, in hospitals that have a CT scanner, there are no additional capital costs. The tariff cost for standard care is £1,357, which captures the costs of image-guided biopsy and full pulmonary function testing.
Resource consequences
The Archimedes System has been used in 7 hospitals in the UK.
Costs include the cost of the system and staff training. Training takes 2 days and is supported on site by the company.
The potential barrier to adoption is the capital cost of the system. Minimal changes in facilities or infrastructure are needed. This is because the procedure can either be done under sedation in the bronchoscopy suite by respiratory physicians, or be done under general anaesthetic in the operating theatre by thoracic surgeons. Using Archimedes for more invasive procedures such as BTPNA may require more facilities than the sedation available in a bronchoscopy suite.
There may be cost savings from fewer complications such as pneumothorax and a shorter inpatient stay. It does not take long to do a CT-guided trans-thoracic needle biopsy procedure, and it is done under local anaesthetic. But there may be some people for whom CT‑guided biopsy is too high risk because of comorbidities, or if a leading airway path to the lesions cannot be identified. One expert noted that another CT may be needed before the procedure, and this means extra hospital visits.