Anaheim-based ClearFlow Inc. is changing the surgical game in regard to chest tubes.
Open-heart surgery is scary enough for most patients—the risk of complications is a factor that patients and physicians try to weigh before making any major operative decisions. Even the best plan can go awry simply because the technology used to mitigate unforeseen situations does not exist yet.
Following cardiothoracic surgery, a chest tube is inserted into the chest cavity to assist with drainage. It is important that blood be able to flow through the tube. About 36% of postoperative patients suffer from completely blocked chest tubes.
ClearFlow said a clinical trial completed earlier this year showed that its PleuraFlow ACT reduced that number to 11%. The company presented its findings last May to the American Association for Thoracic Surgery 99th Annual meeting in Toronto.
The company was founded by cardiothoracic surgeon Dr. Ed Boyle, an inventor of many medical devices.
“At the bedside, when bleeding stops abruptly, the question is, did it really stop? Or did it just stop draining? If a patient is bleeding internally, it can quickly become life threatening,” Boyle said on his website.
“As a cardiothoracic surgeon looking at post-surgery X-rays, I would often see the chest tube sitting right in the middle of a fluid collection. And I wondered, why is that? This tube is sitting right there, in the middle of the fluid. Isn’t it supposed to drain it?
“My ‘aha’ moment came as I started making the connection between chest tube clogging and blood and fluids retention.”
Magnetic Technology
RBS, or retained blood syndrome, occurs when the drainage in the chest tube becomes blocked with blood and causes postoperative complications. About 17% of such postoperative patients require intervention due to RBS, which carries a price tag around $29,000 and increases a hospital stay by five days, according to the Clearflow website.
The Pleuraflow ACT system is comprised of magnets that can actuate the internal clearance loop and maintain sterility, an action that clears the chest tube.
The company recommends the use of ClearFlow for the first 24 hours post-op. Currently, there are no formal guidelines regarding chest tubes in the ICU.
Boyle, who is chairman of ClearFlow, was a founder of Elixis, a healthcare information technology company which was acquired by Data Critical Corp., now a division of General Electric. Boyle is the founder of MDI, VenX, and Precision Thoracic Corp., all early-stage medical device companies.
ClearFlow’s CEO is Paul Molloy, who was CEO at VasoNova Inc., a Silicon Valley-based, venture-funded vascular navigation company acquired by Teleflex Inc. in January 2011.
