ClearFlow, Inc.

History

ClearFlow, Inc. is a medical device company developing proprietary active wound evacuation systems to speed recovery, reduce complications, and lower healthcare costs in patients recovering from surgery. The company was founded in Bend, OR, as Clear Catheter Systems. The technology is based on the work of Ed Boyle, MD and A. Marc Gillinov, MD, both cardiac surgeons. While developing a proprietary self-clearing catheter system, Boyle came across 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. In early 2014, the company relocated its operations from Bend, OR, to southern California, a world-renowned medical device hub with a strong community and a large pool of experienced talent. On March 1, 2014, Clear Catheter Systems, Inc. changed its name to ClearFlow, Inc. to reflect its focus on helping clinicians eliminate acute, sub-acute, and chronic postoperative complications of current high failure-rate wound drainage tubes.

Products

The company's first product, the PleuraFlow® Active Clearance Technology™ (ACT) System, is intended to actively maintain wound drainage catheter patency after open cardiac and thoracic surgical procedures. The system received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) in December 2010, and is also approved for use in Canada and Europe.

The device is used in cardiothoracic surgical procedures like coronary artery bypass surgery, heart valve replacement and repair surgery or Ventricular Assist Device surgery to improve the evacuation of post-surgical blood from the pericardial and pleural spaces. The catheter system includes a chest tube and an internal clearance apparatus that allows clinicians to clear away obstructions that can form inside as a result of blood clotting. The clearance apparatus 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 cause chest tube clogging, which can prevent fluid from draining and cause such clinical complications as pericardial tamponade, hemothorax, pleural effusions, and increased mortality. Conventional techniques to clear these obstructions, including chest tube milking and stripping, have not been shown to be effective. They also 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 preclinical studies. The amount of drainage achieved was three times 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. A prospective clinical study from the Cleveland Clinic has highlighted a greater than 1 in 3 rate (36%) of failure of drainage tubes from clogging for patients undergoing cardiothoracic surgery. And, in 86% of those cases, the obstruction was inside the patient where the clotting couldn’t be observed by the nursing staff.

Ineffective evacuation of blood and fluid around the heart and lungs due to chest tube clogging after surgery leads to Retained Blood Complications (RBC). RBC is a composite term describing one or more single or combined complications (acute, sub-acute and chronic) such as cardiac tamponade, hemothorax, bloody pleural and pericardial effusions, and fibrothorax which occur in 15-25% of cardiac surgery patients. In a review of over 300,000 adult US Cardiac Surgery patients from the National Inpatient Sample (NIS) from 2010 it was shown that 17% of all patients experience one or more RBC which lead to:

a. Increased cost of care (55% higher)

b. Increased Length of stay (15 days vs. 10 days)

c. Doubled mortality rates (6% vs. 3%)

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 Gold 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 criterion for the award selection is based on if the design of a product can enrich society and people's lives.

In 2013, the company was awarded the top prize for best cardiovascular start up at the Innovations in Cardiovascular Interventions (ICI) conference in Tel Aviv, Israel. The honor was awarded to Dr. Edward Boyle, a surgeon, Chairman of ClearFlow, Inc. and an inventor of the PleuraFlow® device, which prevents chest tube clogging to minimize the problem of Retained Blood Complications, RBC after heart surgery. The ICI brings together thousands of participants from around the world, representing the healthcare industry, governments, hospitals, venture capital funds, prominent scientists and key opinion leaders in the cardiovascular field. The ICI Innovation Award is the world’s most prestigious award for cardiovascular start-ups. Finalists were selected in a rigorous peer reviewed process by a panel of judges. {http://2014.icimeeting.com}