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 European markets.
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.mdipartners.com). Clear Catheter?s 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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PleuraFlow is a registered trademark of Clear Catheter Systems. Other company and
product names may be trademarks of their respective owners.
Media inquiries:
Kelly Herman
kellyherman&co
kelly@kellyherman.com
(541) 419-8855
Clear Catheter Systems Announces CE Mark Approval and
European Launch of the PleuraFlow™ Active Tube Clearance System
MDI Partners supports the development of promising medical device technologies for smaller markets
