Clear Catheter Systems Announces CE Mark Approval
Clear Catheter Systems Announces CE Mark Approval and European Launch of the PleuraFlow® Active Tube Clearance® System
BEND, Oregon – June 18, 2010 – Clear Catheter Systems announces CE Mark approval
of its PleuraFlow® Active Tube Clearance® System. This approval allows for the
marketing and sale of the PleuraFlow® Active Tube Clearance® System in Europe. With
receipt of the CE Mark approval, Clear Catheter this week launched the product in
The PleuraFlow® Active Tube Clearance® System is a novel chest tube clearance apparatus
developed to maintain chest tube patency. Chest tubes are required for nearly all heart
and lung operations, and often for chest trauma. Clogging of a chest tube with a clot in
the setting of continued postoperative drainage can contribute poor outcomes and even
death. Chest tube clearance with the PleuraFlow® is achieved by advancing the
specially designed clearance member back and forth within the chest tube under sterile
conditions, breaking down and pulling clots back out of the tube, thereby leaving the
inner portion of the chest tube clear of any obstructing material.
PleuraFlow® has been approved for marketing in Canada by Health Canada, and the
company has applied to the U.S. Food and Drug Administration for 510(k) clearance in
the United States.
In late 2009, Clear Catheter Systems was awarded the prestigious European
Association of Cardiothoracic Surgery (EACTS) Techno-College Innovation Award for its
PleuraFlow® Active Tube Clearance® System. The Techno-College Award is a worldwide
competition to identify innovations that have the potential to change the standard of care
in heart and lung surgery.
About Clear Catheter Systems
Clear Catheter Systems (www.clearcatheter.com) is a medical device company located
in Cleveland, Ohio and Bend, Oregon, developing proprietary medical tube clearance
platform based on technology developed at Cleveland Clinic and MDI Partners,
(www.mdipartnersllc.com). Clear Catheterʼs ultimate goal is to develop its tube
clearance platform to help make surgery safer for heart, lung and trauma patients, as
well as in markets beyond cardiothoracic surgery.
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