BD wins expanded FDA 510(k) clearance for PleurX cath system

Becton Dickinson & Co. (NYSE:BDX) said today it won expanded FDA 510(k) clearance for its PleurX catheter system.

The PleurX catheter system is now cleared for use in treating non-malignant recurrent pleural effusions etiologies, including congestive heart failure and cardiogenic effusions, the Franklin Lakes, N.J.-based company said.

“Our research found that the Pleurx catheter provided palliation of congestive heart failure patients’ pleural effusions and freedom from re-intervention equal to that of talc pleurodesis using thoracoscopy while resulting in a shorter mean length of hospital stay. Lower rates of operative morbidity and readmission related to the pleural effusion were also seen in the Pleurx catheter treatment group,” Dr. Richard Freeman of St Vincent Indianapolis said in prepared remarks.

The company’s newly cleared catheter system is designed to drain pleural fluid which accumulates in the pleural cavity that surrounds the lungs and can cause shortness of breath. The device can be used in at home settings, BD said.

“The benefits of the PleurX catheter system when used for congestive heart failure patients with recurrent pleural effusions include the ability to drain at home and the option to be performed as an outpatient procedure, this may lead to less visits to the office and hospital and a shorter length of stay,” Dr. David Sternberg of Farmington Hills, Mich.’s Beaumont Hospital said in a prepared statement.

The PleurX catheter system won initial approval in 1997, cleared for managing malignant and recurrent pleural effusions.

“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,” infection prevention, V. Mueller and interventional specialties GM Jim Leitl said in a press release.

Last September, Becton Dickinson won FDA 510(k) clearance for its Vacutainer Barricor plasma blood collection tube.

The company touted improvements to the next-gen blood collection and separation device, saying its designed to improve sample quality, speed up result returns and improve patient care and clinical efficiency.

The BD Barricor tube is a single-use, plastic, evacuated tube obtain plasma for in vitro diagnostic use, and operates with a novel mechanical separation technology to obtain plasma from whole blood samples. The company said the mechanical separator technology is designed to reduce centrifugation time from 10 minutes to 3 minutes and reduce cellular contamination by 50 to 65% compared to plasma gel tubes.

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