Updated 7:35 p.m.
A pre-clinical evaluation of a self-clearing chest tube developed by Clear Catheter Systems Inc. has demonstrated the tube that clears itself works better to drain the chest after surgery than a passive tube of the same size.
The Cleveland Clinic spin-off based in Cleveland and Bend, Ore., is applying for U.S. and European market clearance to sell its PleuraFlow Active Tube Clearance System.
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“This is the first study to demonstrate that active chest tube clearance improved drainage compared to a standard chest tube of the same size,” said Dr. Edward Boyle, chief executive of Clear Catheter Systems, in a press release.
PleuraFlow uses magnets and a wire loop to keep itself clear while draining blood and other fluids from the chest after heart or lung surgery. Passive tubes can clog, posing threats like complications and death, said Dr. Kiyotaka Fukamachi, a cardiac surgery researcher at the Cleveland Clinic’s Lerner Research Institute and director of the study, in the release.
“In the laboratory, we are finding that active chest tube clearance improves drainage and reduced the degree of retained hemothorax compared to a standard chest tube,” Fukamachi said.
PleuraFlow might also help doctors.
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“This study suggests that an active tube clearance system may provide clinicians with a better way to safely manage the growing number of patients with a tendency to bleed when on powerful anti-platelet agents and who need to maintain functioning chest tubes while their platelets are replaced in the early postoperative period,” said Dr. Marc Gillinov, staff cardiac surgeon at the Clinic and co-inventor of the device.
The pre-clinical data has been published in the May edition of the Interactive Cardiovascular and Thoracic Surgery Journal.
CEO Boyle, a cardiovascular and thoracic surgeon in Oregon, had watched his patients endure the discomfort of having large tubes — the patients called them “garden hoses” — inserted in their chests to drain fluid and air after heart or lung surgery.
Worse, the tubes, called catheters, tended to clog. While working on a technology to solve his patients’ problem, Boyle found a patent on the same subject by the Clinic’s Gillinov, also a cardiovascular and thoracic surgeon. The two agreed to work together.
Clear Catheter Systems closed its initial round of seed investment (pdf) from the Cleveland Clinic and Bend Venture Angel Investors in August 2007. A year later, the company raised $600,000 from the Cleveland Clinic-led Global Cardiovascular Innovation Center; Xgen Ltd., a Cleveland investment partnership primarily owned by the family of radio and dot-com mogul Tom Embrescia; and angel investors in Oregon.
In July 2008, Boyle said his company would use the second investment to move from an early development stage through prototyping, testing and FDA approval of its leading device. Clear Catheter still is waiting for regulator approval to sell PleuraFlow here and in Europe.
Boyle also said in 2008 that his company “would require a lot more funding” to do a formal product launch of its active chest tube. That’s still true. “The company is currently seeking funding for the clinical launch of this product,” he said through a spokeswoman.
In October, PleuraFlow won the 2009 EACTS TechnoCollege Innovation Award, which is given by the European Association of Cardio-Thoracic Surgery to recognize the year’s most important technological breakthrough related to thoracic and cardiovascular surgery.
Clear Catheter hopes to develop its tube-clearance platform to help heart, lung and trauma patients, and then other patients.