Cleveland Clinic spinoff Clear Catheter Systems, which recently closed a $1.2 million angel investment round, received Food & Drug Administration 510(k) clearance to sell its PleuraFlow Active Tube-Clearance System in the United States.
PleuraFlow keeps catheters clear while draining blood and other fluids from the chest after heart or lung surgery. The device has the potential to improve patient outcomes, said Dr. Edward Boyle, Clear Catheter’s CEO.
“We think this is a product that is going to be a huge breakthrough in managing patients after heart and lung surgery,” Boyle said. “When chest tubes don’t drain well people end up with trouble after surgery.”
The device, which already is cleared for sale in Europe and Canada, also could lower healthcare costs by enabling hospitals to increase their efficiency and lower the risk of patient complications — both goals of recent healthcare reform laws.
It could even help doctors better and more safely manage the growing number of patients with a tendency to bleed when they’re put on powerful anti-platelet agents after surgery.
Boyle, a cardiovascular and thoracic surgeon in Oregon, came up with the idea for an active-clearing catheter system while watching 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. That led to buildup of blood around the heart and lungs, which could lead to complications and even death.
While researching patents on such devices, Boyle found a patent by the Cleveland Clinic’s Dr. Marc Gillinov, also a cardiovascular and thoracic surgeon. The two agreed to work together on PleuraFlow.
The Clinic spun off Clear Catheter Systems, then known as PleuraFlow LLC, in 2007. The company closed its initial round of seed investment (PDF) from the Cleveland Clinic and Bend Venture Angel Investors in August of that year.
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.
During its latest funding cycle, Clear Catheter evaluated more Ohio investment opportunities but decided to go with $1.2 million from a West Coast group led by Oregon Angel Fund, Boyle said. The recent funding brings to $2.2 million the amount the company has raised since its founding. Cleveland Clinic remains a development partner.
Boyle, who had been his company’s sole employee, has hired a global director of sales and marketing to strike relationships with specialty critical care and cardiovascular products distributors. An Arizona company makes the PleuraFlow system.
“This is a huge step for us,” Boyle said. “It positions us so we can begin the commercialization efforts here in the U.S.”