CytoSorbents (OTC:CTSO) announced that it received FDA breakthrough device designation for its CytoSorb blood purification technology for use during emergent and urgent cardiothoracic surgery.
Monmouth Junction, N.J.-based CytoSorbents designed its CytoSorb technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients.
The FDA breakthrough nod is for the use of CytoSorb for the removal of ticagrelor in a cardiopulmonary bypass circuit during cardiothoracic surgery. Ticagrelor, a blood thinner, can bring the risk of serious or life-threatening bleeding in users who require emergent cardiac surgeries. Currently, there are no approved or cleared theories in the U.S. to rapidly reverse the effects of or remove ticagrelor in these cases, according to a news release.
CytoSorbents already has approval for use of the CytoSorb technology in removing ticagrelor after receiving CE Mark approval in Europe in January.
“We are excited to receive FDA breakthrough designation of CytoSorb for the removal of ticagrelor during emergent and urgent cardiothoracic surgery,” CytoSorbents COO Vincent Capponi said in the release. “We believe this represents an important step towards our goal of obtaining U.S. regulatory approval of CytoSorb for this indication.
Last week, CytoSorbents earned FDA emergency use authorization (EUA) for use of the CytoSorb technology in COVID-19 patients. It is touted as being capable of reducing the cytokine storm and inflammatory response commonly seen in COVID-19 patients.
