- The Spirotome Flex passed succesfully extensive preclinical and clinical phase 1 and 2 trials.
- Compared to the forceps, the sample is about 20 times larger
- Compared to cryo, the sample is twofold larger.
As for all types of cancers, curability increases when lesions are found in an early stage. CT-scan of the thorax is the preferred tool to examine thoracic symptoms. Often, small nodules can be seen at the periphery of the lungs that are out of reach for classical bronchoscopy and too small for transthoracic biopsy. These challenging nodules are often suspect for adenocarcinoma or metastasis. They need biopsy to diagnose cancer and at the same time, to characterize this cancer with histology and molecular biology for optimal treatment. Up to now, only cytology (needle, brush) or very small superficial biopsies (forceps) are possible, but the rate of successful diagnosis is not higher than 60 to 70%.
The ScoFlex project 2020 proved that the true positive rate can increase to beyond 90% with full characterization of the biological behavior. It was the start of extensive clinical trials that are described in literature. Tumors found in early stage, with proper subtyping and molecular profiling can be cured in over 80% of lung cancer patients.
How the product is used is described in the IFU.
More details: catalogue
