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Clear Catheter Systems Receives US FDA Clearance for the PleuraFlow Active Tube Clearance System



12/13/2010 7:43:58 AM

BEND, Ore.--(BUSINESS WIRE)-- Clear Catheter Systems, Inc., a Bend, Oregon-based medical device company, announced today that it has received US Food and Drug Administration clearance for its innovative PleuraFlow™ Active Tube Clearance System. This is a device that can be widely deployed in the post operative management of patients requiring heart and lung surgery. The company has approval to market the device in Europe and Canada, and this regulatory approval clears the way to market the product in the United States for patients recovering from cardiothoracic surgery.

When chest tubes become clogged blood can build up around the heart and lungs, which can lead to complications and even death. The PleuraFlow System employs a proprietary active tube clearance system which allows the medical professional to maintain a functioning chest tube in the post operative period.

“This device has the potential to help minimize the risk of surgery, avoid complications and reduce the cost of care for patients recovering from heart surgery,” said Edward Boyle, the company’s Chief Executive Officer. “We are pleased to be able to move forward with our US commercialization plans at this time.”

About Clear Catheter Systems, Inc.

Clear Catheter Systems is a Bend, Oregon based medical device company developing an anti-clogging platform of surgical drainage devices. Its lead product is the PleuraFlow Catheter, which addresses the problem of chest tube clogging after heart and lung surgery. In addition, Clear Catheter has a pipeline of products based on its proprietary tube clearance technology to treat tube clogging in other medical market segments, including a system for the urinary catheter drainage market, the enteral feeding sector as well as systems for standard surgical drains. (www.clearcatheter.com)

PleuraFlow is a registered trademark of Clear Catheter Systems. Other company and product names may be trademarks of their respective owners.



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