CytoSorbents Files IDE for CytoSorb Cardiac Surgery Trial
CytoSorbents said Tuesday it has submitted an investigational device exemption application to the FDA to conduct a clinical trial using CytoSorb during complex cardiac surgeries requiring the use of a heart-lung machine.
The product, an outer-body cytokine absorber already available in the EU, reduces inflammatory agents that are created during surgery and can lead to severe postoperative complications.
According to the company, CytoSorb installs easily into a bypass circuit in a standard heart-lung machine and uses biocompatible, highly porous polymer beads to remove toxic substances from blood and bodily fluids.
Using CytoSorb intraoperatively signifies a new strategy to improve the safety of complex cardiac surgical cases and reduce surgery-generated inflammation, says Robert Bartlett, chief medical officer at the Monmouth, N.J., devicemaker. The trial will get underway as soon as approval is granted.
Roughly 500,000 valve replacement and coronary bypass graft surgeries are performed annually in the U.S. — Kellen Owings