business reasons

VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.

Inclusion Criteria:

• Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
• Subject has air leak present on at least the 5th day following origination.

Exclusion Criteria:

• Subject has air leak only on forced exhalation or cough
• Subject has sepsis
• Subject has pneumonia
• Subject has Acute Respiratory Distress Syndrome (ARDS)
• Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
• Subject has undergone a bone marrow transplant
• Subject has a primary pneumothorax
• Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.