The US Food and Drug Administration (FDA) has expanded its 510(k) clearance for Becton, Dickinson and Company’s (BD) PeritX Peritoneal Catheter System to drain symptomatic, recurrent, non-malignant ascites.
Launched in 2005, as PleurX Peritoneal Catheter System to drain malignant ascites, the device is rebranded as PeritX Peritoneal Catheter System with the expanded indication.
BD noted that PeritX is the first FDA-cleared tunnelled catheter for at-home malignant and non-malignant ascites drainage as well as the mitigation of symptoms linked to recurrent ascites.
The device’s rebranding is expected to aid doctors to navigate the company’s at-home drainage products portfolio easily.
A debilitating condition, ascites causes fluid accumulation in the abdomen, which can make day-to-day activities challenging.
Furthermore, the fluid can move to the chest and surround the lungs, causing difficulty in breathing.
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People with the condition must regularly visit the hospital for the removal of fluid from the peritoneum.
The company’s system features active vacuum technology to aid in ascites fluid drainage at home, offering relief from the discomfort caused by fluid accumulation and avoiding hospital visits.
BD peripheral intervention worldwide president Padraic O’Brien said: “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.
“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.”
Last month, BD received CE mark for its at-home self-collection claim for BD Onclarity HPV Assay for human papillomavirus (HPV) screening.
This approval aids laboratories and facilities to process self-collected samples using a BD diluent tube with the HPV assay on BD Viper LT and BD COR Systems.
The assay can detect 14 high-risk HPV types with a single analysis, the company noted.