Bearpac Medical received CE Mark certification for use of the Passio Pump Drainage System with indications for the intermittent drainage of recurrent and symptomatic pleural effusions and malignant ascites.
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 effusions and malignant ascites. 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, the CE Mark for the Passio system is another important milestone. This new indication and expansion to CE provides Bearpac with an opportunity to now introduce Passio to patients and physicians around the globe,” says Jay Zimmerman, president of Bearpac Medical.
The CE Mark confirms that Passio meets quality standards for design, manufacture, and final inspection. The certification enables Bearpac Medical to market Passio in European Economic Area (EEA) member countries as the company explores expansion opportunities in Europe as part of its global strategy.