Clot-removal device used in pediatric cardiac surgery launched
ClearFlow Inc. announced it has launched in the U.S. market a device to remove clots from chest tubes used in pediatric cardiac or cardiothoracic surgery.
The device (PleuraFlow Active Clearance Technology, ClearFlow) is 20F with four side holes and received clearance from the FDA earlier in 2016, according to a press release issued by the company.
Chest tubes often clog during cardiothoracic surgery, especially the smaller-diameter tubes used for pediatric patients, and can often lead to retained blood syndrome, the company stated in the release.
Clogging of the chest tube is often dealt with via improvised bedside techniques or suction or balloon catheters that break the sterile field, but “these techniques are ineffective and potentially harmful,” the company stated in the release.
“There has long been a need to facilitate patency of chest tubes in the smallest diameters used for pediatric heart surgery since the smaller the tube, the more prone it is to occlude,” Ed Boyle, MD, a cardiovascular and thoracic surgeon at St. Charles Medical Center in Bend, Oregon, and co-founder and chairman of ClearFlow, said in the release. “Expanding the product offerings to facilitate prevention of chest tube clogging in children requiring complex heart operations is an important step to meet this unmet critical need.”
One study demonstrated that a 20F chest tube with the clearance technology did a better job of clearing blood clots than a 32F chest tube without the technology, the company stated in the release.
Two other versions of the device also are available: 20F with six side holes and 24F, according to the release. – by Erik Swain
Disclosure: Boyle is co-founder of ClearFlow and Elixis and founder of MDI, Precision Thoracic Corp. and VenX.