FDA expands indication for BD's system to treat pleural effusion

With the new clearance, patients may now use the PleurX system to treat non-malignant, recurrent pleural effusion.

The FDA has cleared Becton Dickinson’s catheter system for the treatment of non-malignant, recurrent causes of pleural effusion, or the collection of fluid next to the lungs. This clearance expanded the system’s indication beyond malignant and recurrent causes of the condition.

Pleural effusion causes a buildup of fluid between the lungs and the tissue that lines the chest cavity. It can cause shortness of breath, coughing and chest pain. BD’s PleurX catheter system enables patients to drain pleural fluid at home instead of requiring them to return to the hospital for thoracentesis, which treats the condition by draining the fluid through the chest wall.

With the new clearance, the PleurX system is now indicated for certain non-malignant causes of pleural effusion, such as congestive heart failure and cardiogenic effusions. The system was first approved in 1997 to treat malignant causes of pleural effusion, such as pleural mesothelioma and lymphoma.

"The system helps patients take control of their therapy by enabling them to manage fluid from pleural effusions outside of the hospital. Patients now have the option to potentially avoid the mental and physical toll of undergoing an additional hospital procedure," said Jim Leitl, worldwide vice president and general manager of infection prevention of the V. Mueller line of laparoscopic devices and interventional specialties at BD, in a statement.