BD's at-home drainage system lands first FDA nods spanning both cancerous and benign fluid buildup

FDA
The PeritX Peritoneal Catheter System allows patients with either malignant or nonmalignant ascites to drain the built-up fluids from their abdomen in the comfort of their own home, rather than making frequent trips to the clinic. (Andrew Harnik, Associated Press)

An apple a day may keep the doctor away, but an at-home catheter system from BD has the potential to keep the entire hospital away. The PeritX system allows patients with ascites to regularly drain the fluid buildups from their abdomen from the comfort of their own homes instead of traveling to the clinic for the procedure.

The system includes a tunneled catheter connected to a drainage bag, coupled with an active vacuum to suction out the fluid from the abdominal cavity. Before use, patients and their caregivers are trained by their clinical teams to use PeritX at home, where they can administer the treatment themselves as often as recommended, typically every one or two days.

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Ascites are typically linked to liver failure, with the majority of cases labeled as nonmalignant and caused by cirrhosis, as well as heart failure, pancreatitis and other noncancerous diseases. However, about 10% of cases are linked to malignancy, and are commonly found in people with cancers of the breast, colon, gastrointestinal tract and other organs.

Now, BD’s offering can be used to treat the entire spectrum of ascites. It was initially introduced in 2005 as PleurX and cleared only for use in malignant cases. A decade and a half later, however, the FDA has broadened its 510(k) of the system, allowing it to be used to drain symptomatic, recurrent and nonmalignant ascites.

With the FDA’s newly expanded indication of the device—making it the first tunneled catheter cleared for use in treating both types of ascites—BD promptly rebranded it as PeritX.

“Patients with ascites are often managing multiple serious medical conditions," Padraic O’Brien, BD’s worldwide president of peripheral intervention, said in a statement. "The PeritX Peritoneal Catheter System provides relief from the discomfort of ascites fluid buildup, at home, enabling patients to spend more time with their loved ones.”

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BD’s system may be the first cleared by the FDA to treat all forms of ascites, but it’s not the only one in development for at-home use. The Belgian company Sequana Medical is developing a fully implantable pump that siphons fluid out of the peritoneum and into the bladder, where it can be excreted naturally.

Sequana’s Alfapump received the FDA’s breakthrough-device designation in early 2019, mere days before the company went public with a Belgian IPO that brought in about $32 million. It has since launched a large clinical trial of the system with hopes of landing an FDA clearance for the Alfapump, which has already been cleared for commercial use in Europe.