BD’s PleurX catheter system receives FDA 510(k) approval

Becton, Dickinson and Company’s (BD) PleurX catheter system has received 510(k) from the US Food and Drug Administration (FDA) for use in specific non-alignment recurrent pleural effusions etiologies like congestive heart failure.

The PleurX catheter system is helpful in patients suffering from a pleural effusion, which is a collection of fluid accumulating in the pleural cavity surrounding the lungs and results in shortness of breath.

The new product offers patients with the option to drain pleural fluid at their homes and helps in avoiding the need for multiple visits to hospitals for thoracentesis procedures.

The product received approval initially in 1997 to manage malignant and recurrent pleural effusions.

BD worldwide vice president and V. Mueller and Interventional Specialties Infection Prevention general manager Jim Leitl said: "This indication of the PleurX catheter system means BD can provide patients who suffer from recurrent pleural effusions due to congestive heart failure and other non-malignant recurrent pleural effusion etiologies with an option to manage their symptoms from the comfort of their home.

"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."

St Vincent Indianapolis regional chief medical officer Dr. Richard K. Freeman claims to have conducted research on the catheter system and noted that it offered palliation of congestive heart failure patients’ pleural effusions and freedom from re-intervention equal to that of talc pleurodesis using thoracoscopy while reducing the stay in hospital.

Apart from this, operative morbidity and readmission related to pleural effusion were seen to have been lowered in the PleurX catheter treatment group.

Established in 1897, Becton, Dickinson has been in the field of medical technology manufacturing medical devices, instrument systems and reagents. Presently, with a workforce of about 40,000 it has a presence in more than 50 countries.