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BD Announces Expanded 510(k) Clearance for At-Home System for Ascites

PeritX Peritoneal Catheter System is the first and only at-home system indicated for malignant and non-malignant ascites drainage in the United States.

BD (Becton, Dickinson and Company), a leading global medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the PeritX™ Peritoneal Catheter System for the drainage of symptomatic, recurrent non-malignant ascites. Ascites is a debilitating condition that causes the build-up of fluid in the abdomen.

 PeritX Peritoneal Catheter System  

The PleurX™ Peritoneal Catheter System was introduced in 2005 for the drainage of malignant ascites. With the new, expanded indication, the system is being rebranded as the PeritX™ Peritoneal Catheter System to make it easier for physicians to navigate BD's portfolio of at-home drainage products. The PeritX™ Peritoneal Catheter System is the first and only FDA indicated tunneled catheter for the drainage of malignant and non-malignant ascites and for the palliation of symptoms related to recurrent ascites.

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"The new, expanded indication for the PeritX™ Peritoneal Catheter System will allow us to help more patients who present with ascites due to liver disease or other noncancer-related origins," said Padraic O'Brien, Worldwide President of Peripheral Intervention for BD. "Recurrent ascites is a debilitating condition that requires the patient to make frequent trips to the hospital so that fluid can be removed from the peritoneum. The PeritX™ Peritoneal Catheter System allows patients to manage non-malignant ascites at home and aligns with our goal to help keep patients out of the hospital."

Ascites is a condition in which fluid collects in spaces within the abdomen. It can make ordinary daily activities more challenging. The fluid may also move to the chest and surround the lungs, making breathing more difficult.

"Patients with ascites are often managing multiple serious medical conditions. The PeritX™ Peritoneal Catheter System provides relief from the discomfort of ascites fluid build-up, at home, enabling patients to spend more time with their loved ones," O'Brien concluded.

Source: BD
Date: Jun 23, 2021


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