CytoSorbents has been granted a second breakthrough device designation for its DrugSorb-ATR antithrombotic removal system by the US Food and Drug Administration (FDA).
This breakthrough device designation covers the removal of the direct oral anticoagulants (DOACs) apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery. It follows the breakthrough designation received in April 2020 to remove ticagrelor for the same application.
David Cox, vice president of global regulatory affairs of CytoSorbents, said: “The US prescribing information for apixaban and rivaroxaban, two leading DOACs taken to reduce the risk of blood clots and associated complications, clearly warns that dosing should be stopped prior to a surgical procedure to reduce the risk of bleeding. Unfortunately, in unexpected urgent cardiothoracic surgery, this is often not possible, posing the risk of life-threatening bleeding in these patients.
“We are pleased that the FDA has recognised the potential of our DrugSorb-ATR Antithrombotic Removal System to reduce levels of these drugs in a patient’s blood, potentially decreasing the risk of life-threatening perioperative bleeding. The achievement of two breakthrough designations in these situations where no approved or cleared alternatives exist is a major company milestone that is expected to expedite our regulatory and clinical goals.”
Vincent Capponi, president and chief operating officer of CytoSorbents, said: “We are pleased that the DrugSorb-ATR Antithrombotic Removal System has been granted a second breakthrough device designation by the FDA. With this achievement, we continue to execute upon our multi-phase US strategy to potentially establish DrugSorb-ATR as an easy-to-implement, new standard of care to remove antithrombotic drugs during cardiothoracic surgery.
“The US STAR-T (Safe and Timely Antithrombotic Removal‒Ticagrelor) pivotal randomised, controlled clinical trial is now underway and we look forward to working with the FDA in pursuit of the next IDE approval for the U.S. study on DOAC removal during cardiothoracic surgery. We estimate the total addressable market for DrugSorb-ATR to remove ticagrelor, apixaban, and rivaroxaban during cardiothoracic surgery is more than US$500 million in the USA alone today, which is expected to significantly increase based on prescribing trends and generic availability of these drugs.”