Chest Drainage System Granted FDA Clearance

FDA 510(k) clearance for the Passio Pump Drainage System for malignant ascites & pleural effusions.

Image credits: Bearpac Medical

Bearpac Medical, LLC announced that the FDA has granted 510(k) clearance for its Passio Pump Drainage System for the additional indication of peritoneal to provide therapy for malignant ascites in addition to recurrent pleural effusions.

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic malignant ascites as well as recurrent and symptomatic pleural effusions. The Passio pump is attached to an implanted Passio catheter using the disposable collection kit and is activated to begin the evacuation of fluid into the collection bag. The Passio catheter is exclusively designed for use with the Passio collection system. Passio provides flow control throughout the therapy at lower vacuum pressures than competitive devices on the market today.

Read more: New Wearable to Assess Lung Function

"We are very excited for the expanded indication so that we can now offer Passio to more patients dealing with these difficult diagnoses," said Jay Zimmerman, President of Bearpac Medical.

About Bearpac Medical

Bearpac Medical is a privately held medical technology company headquartered in New Hampshire, focused on the development of novel thoracic drainage products to improve the lives of patients experiencing pleural effusions.

Sam Draper
January 12, 2024

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