Clear Catheter Systems

Clear Catheter Systems, Inc is a privately owned medical device manufacturer based in Bend, Oregon. The company was founded in 2007, the result of a collaboration between the Cleveland Clinic Foundation and Medical Device Innovations, LLC. The Oregon-based company manufactures anti-clogging catheter systems based on its proprietary tube clearance technology.

History

Clear Catheter Systems was founded to develop a family of catheters with anti-clogging technology. The technology is based on the work of Ed Boyle, MD and A. Marc Gillinov, MD, both cardiac surgeons. While researching patents for a self-clearing catheter system, Boyle found a patent by Gillinov, and The Two agreed to work together. In 2007, the Cleveland Clinic Foundation spun off Clear Catheter Systems, then known as PleuraFlow, LLC.

Products

The company's first product on market, PleuraFlow ACTIVE Tube Clearance System, is a chest tube system intended to PReVENT chest tube clogging. Chest tube clogging can occur after cardiac and thoracic surgery when the draining blood clots inside of the chest tube. The system received 510(k) regulatory clearance from the U.S. Food and [...] Administration (FDA) in December 2010, and is also approved for use in Canada and Europe.

The device is used in cardiac and thoracic surgical procedures like coronary artery bypass surgery to prevent fluid accumulation around the heart and lungs after surgery. The catheter system includes a chest tube and an internal clearance mechanism that allows healthcare providers to clear away obstructions that can form inside as a result of blood clotting. The clearance mechanism uses a wire with a loop that is magnetically coupled to an external handle to allow the obstructions to be cleared without breaking the sterile environment. If these obstructions are not cleared away, they can lead to chest tube clogging, which can prevent fluid from draining and cause such clinical complications as pericardial tamponade and hemothorax. Conventional techniques to clear these obstructions, including chest tube milking and stripping, have not been shown to be effective and significantly increase negative intrathoracic pressures that can harm internal structures and potentially impair post-operative recovery. To combat the suboptimal methods of responding to chest tube clogging, many surgeons employ large-diameter chest tubes though they are thought to be associated with more pain.

Clinical evidence

The PleuraFlow system was shown to significantly improve drainage compared to a conventional chest tube of the same size in animal models. The amount of drainage achieved was significantly higher than that with the standard tube, and the amount of retained blood and clots inside the pleural space was significantly lower than that with the standard tube. In a subsequent study, significantly improved drainage was demonstrated with a smaller (20 Fr) PleuraFlow chest tube as compared to a larger (32 Fr) standard chest tube. This is the first time that a smaller diameter chest tube has been shown to provide superior drainage over a larger chest tube.

Awards

PleuraFlow was awarded the 2009 European Association of Cardiothoracic Surgery (EACTS) Techno-College Innovation Award. 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.,

In 2011, the PleuraFlow system was awarded a Medical Design Excellence Award (MDEA). The MDEA is awards manufacturers of medical technology devices, recognizing the achievements of the manufacturers and designers that are responsible for healthcare innovations.

The PleuraFlow Active Tube Clearance System was one of the 2011 award winners of the 49th Annual R&D 100 Awards. The R&D 100 Awards recognize the 100 most significant research and development advances, and is a mark of excellence recognized as proof that the product is one of the most innovative IDeaS of the year.

The PleuraFlow system was recognized at the 2011 Good Design Awards in the medical category. The awards aim to internationally recognize designers and manufactures that go above and beyond ordinary consumer design to create innovative and original products. A primary criteria for the award selection is based on if the design of a product can enrich society and people's lives.