Lung cancer is the most common cancer worldwide with over 1.8 million new cases diagnosed annually. It was responsible for 1.6 million cancer deaths worldwide in 2012. Lung cancer has a 5 year survival rate of only 10%, in part due to late diagnosis. Early detection and diagnosis of lung cancer is vital as it reduces morbidity and saves lives. CT-guided transthoracic needle biopsy (TTNB) is the gold standard for lung cancer diagnosis and histological evaluation.
Although it is generally regarded as a safe procedure, complications exist, the most common being pneumothorax. Pneumothorax, or a collapsed lung, is caused by the needle puncturing the lung during a TTNB. Air then leaks through the hole created by the needle into the pleural cavity and leads to uncoupling of the lung and chest wall. The air pushes on the outside of the lung and causes it to collapse. This leads to an oxygen shortage, impaired ventilation and significant morbidity for the patient.
The clinically reported rate of pneumothorax ranges from 15-42%. Treatment of pneumothorax via intercostal chest tube placement is required in up to 20% of all cases. This substantially increases the cost of care by converting an outpatient procedure to one mandating hospitalization. SELIO will prevent a pneumothorax during TTNB and thereby reduce patient morbidity, eliminate further clinical intervention and significantly reduce health provider and insurer costs.
The SELIO System is a first-in-class medical device designed specifically to address the complication of lung biopsy related pneumothorax.
Pneumothorax, or collapsed lung, is the most common, costly and dangerous complication associated with percutaneous lung biopsy. As a result of puncturing the lung, air leaks into the pleural cavity and pushes the lung away from the chest wall, causing it to collapse.
All previous attempts to tackle this problem have focused on plugging the needle tract in the lung post-biopsy and have proven ineffective. SELIO is revolutionary as it forms a temporary pleural seal pre-biopsy. The biopsy is carried out through this air tight seal and in doing so a pneumothorax is prevented during and after the biopsy procedure.