By Amanda Pedersen
Senior Staff Writer
A device designed to be installed into a heart-lung machine and used intra-operatively during complex cardiac surgery in an effort to reduce post-operative complications may soon be making its way through the U.S. regulatory process. CytoSorbents (Monmouth Junction, New Jersey) said it has submitted an investigational device exemption (IDE) application to the FDA to conduct a clinical trial of its CytoSorb extracorporeal cytokine adsorber. The goal of CytoSorb treatment is to reduce inflammatory mediators and proteins such as cytokines and plasma free hemoglobin generated during surgery that can lead to serious post-operative complications.
"This is designed to hopefully be a pivotal trial for CytoSorb in the United States that would hopefully lead to its approval here in the U.S.," Phillip Chan, president/CEO of CytoSorbents, told Medical Device Daily. The size of the trial has not been publicly disclosed but Chan said it is designed to be a multi-center trial with more than 100 patients.
"In the U.S. we have a very strong cardiac surgery advisory board, many of whom will be participating in the clinical trial," Chan said. He noted several of the heart centers that will participate in the trial, including the University of Kentucky (Lexington), the University of Michigan (Ann Arbor), the Cleveland Clinic, and the University of Pittsburgh.
Chan also noted that the device installs within minutes into a bypass circuit in a heart-lung machine and "it's very seamless in how it's used, very compatible with the procedure."
"Intra-operative use of CytoSorb represents an innovative new strategy to improve the safety of complex cardiac surgical cases, and to reduce inflammation generated during the surgery. Currently, there are no practical alternatives approved in the U.S. or Europe to address this significant problem," said Robert Bartlett, chief medical officer of CytoSorbents, and Greg Di Russo, senior VP of clinical development at CytoSorbents, in a joint statement. "We believe the proposed trial protocol, designed with significant input from our cardiac surgery advisory board, is well-designed to be effectively conducted by our clinical trial sites, which include many of the leading cardiac surgery centers in the country. With approval, we will begin the clinical trial as soon as possible."
CytoSorb is currently approved in Europe as an extra-corporeal cytokine adsorber, the company noted. The device has been used in more than 100 cardiac surgeries in Europe to date. Chan told MDD that in the cases in which the CytoSorb has been used in Europe the response from clinicians has been "very strong" and the technology has led to good outcomes in those patients.
"The submission of this IDE application represents a major milestone for the company, initiating this clinical trial process needed to seek approval of CytoSorb in the U.S.," said Vincent Capponi, chief operating officer of CytoSorbents. "With approximately half a million cardiac surgery procedures such as valve replacement and coronary artery bypass graft (CABG) surgeries each year in the U.S. alone, and another one million in the rest of the world annually, we believe this represents a significant potential commercial opportunity for the company."
Chan added that these are very expensive surgeries. "CABG, for example, costs each person about $75,000 to $100,000 for the surgery," he said. When complications arise, it not only leads to poor patient outcomes but to "extreme costs."
CytoSorb is designed to reduce the "cytokine storm" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis, the company said. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure.
"The goal here is to really try to improve the safety of cardiac surgical procedures and improve patient outcomes," Chan said.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. CytoSorbents also noted that it has "numerous" products under development based upon this blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including HemoDefend, ContrastSorb, DrugSorb, and others.
"We hope that a positive trial here in the U.S. will lead to accelerated usage in cardiac surgery in the rest of the world, in other countries where it is already approved," Chan said. //
Published December 31, 2014