Bearpac Medical, LLC is pleased to announce that the FDA has granted 510(k) clearance for the Passio Pump Drainage System for the additional indication of home use to provide therapy for malignant and other recurrent pleural effusions.
| MOULTONBOROUGH, N.H., Dec. 1, 2020 /PRNewswire/ -- Bearpac Medical, LLC is pleased to announce that the FDA has granted 510(k) clearance for the Passio Pump Drainage System for the additional indication of home use to provide therapy for malignant and other 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 pleural effusion. 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. “As Bearpac builds on our product offering, we are excited to add the home use indication to our pleural indication. Passio, designed to be intuitive, provides patients with the confidence to control their therapy in the comfort of their own homes. We have seen patients quickly embracing our convenient digital platform which differentiates Passio from all other products on the market,” said Jay Zimmerman, President of Bearpac Medical. About Bearpac Medical, LLC
SOURCE Bearpac Medical, LLC |
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