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Bend, OR—December 13, 2010—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…

There was an interesting article on bleeding after heart surgery in the American Heart Journal this month.  The Title is “Clopidogrel loading dose and bleeding outcomes in patients undergoing urgent coronary artery bypass grafting.” The Citation is: Am Heart J 2011 Feb;161(2):404-10. The focus of the study is the impact of Plavix (Clopidogrel) on bleeding after heart surgery.  The investigators found that major bleeding happened in 73% of patients loaded…

Clear Catheter Systems recently attended the German Society of Thoracic and Cardiovascular Surgery in Stuttgart, Germany. Perhaps it was fitting that the motto of the program was “Panta Rhei”, which means “everything flows.” We had some great meetings discussing the importance of adequate chest tube flow with surgeons from all over the region, including surgeons from Germany, Austria and Switzerland. Multiple discussions were held about chest tube clogging…

The company continues to develop and protect its intellectual property.  In 2010, the company filed additional patents and was granted patent approvals, including a US patent that was issued with claims adding protection for the active tube clearance platform.

Jim Fee joined our board as a representative of the Oregon Angel Fund.  Mr. Fee has spent 40 years in the medical device industry having most recently served as Vice-President and General Manager Welch Allyn Defibrillation and, President of Medical Research Laboratories, a Welch Allyn Company. Mr. Fee spent 12 years at Protocol Systems as VP Global Sales and Marketing from start-up through public offering and acquisition by…

The company held its annual Scientific Advisory Board Meeting at the STS in San Diego in late January.  The event included leading surgeons from Cleveland, LA, Minneapolis, Houston and Milwaukee representing some of the top heart surgery programs in the world.  Also attending were current and prospective distribution partners as well as two board members (George Trutza and Jim Fee).  This was an important opportunity to obtain clinical…

2010 was a big year for regulatory approvals. The company announced in Q3 that it had received European and Canadian Regulatory approval, and in December, the company was granted a Class II FDA 510(k) clearance to allow us to market our device in the US as well. The difficult regulatory environment was a hot topic in the medical device industry in 2010 and this represents a major milestone…

Building on our innovation award from the European Association of Cardiothoracic Surgeons award in 2009, the company received additions awards in 2010. PleuraFlow® was awarded an international industrial design distinction award from I.D. Magazine. In addition, PleuraFlow® was awarded a manufacturing excellence award as the top innovation of the year from Fenner, a $1B international manufacturing giant that bought our manufacturing partner, MRI, in 2010.

The company continues to have a strong R & D effort to support the commercial roll out of the PleuraFlow® product. Two of our pre clinical studies were published in internationally recognized peer reviewed journals. In a head to head comparison with a same sized conventional chest tube in the setting of heavy bleeding, the PleuraFlow® drained far more, and significantly prevented residual hemothorax. This article, entitled, “Improved…