STAR–D trial will assess the Drugsorb-ATR system for the removal of apixaban and rivaroxaban during an urgent cardiothoracic surgery
CytoSorbents has obtained the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct the STAR–D trial of DrugSorb-ATR system.
The STAR–D trial will assess the Drugsorb-ATR Antithrombotic System for the removal of apixaban and rivaroxaban during an urgent cardiothoracic surgery.
Apixaban and rivaroxaban are anticoagulant medications, also called blood thinners, used to prevent and reduce the risk of blood clots.
Bristol-Myers Squibb and Pfizer jointly market apixaban under the brand name Eliquis, while Johnson and Johnson’s subsidiary Janssen markets rivaroxaban as Xarelto.
CytoSorbents said that the IDE study will be conducted under the previously granted FDA Breakthrough Device Designation to the DrugSorb-ATR system.
It was indicated for the removal of Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the perioperative bleeding in urgent cardiothoracic surgery.
The STAR–D trial start-up activities are underway, and is expected to commence in the first quarter of 2022, said the company.
CytoSorbents president and chief operating officer Vincent Capponi said: “The full IDE approval of the STAR-D protocol now positions us to execute the next step in our DrugSorb-ATR market development strategy.
“With this additional approval, we will have two U.S. randomized, controlled pivotal trials ongoing to support U.S. FDA marketing approval for the intraoperative removal of the key blockbuster antithrombotic drugs Brilinta, Eliquis and Xarelto during open heart surgery to reduce the risk of perioperative bleeding.
“If successful, we intend to establish DrugSorb-ATR as the go-to, easy-to-use, potential standard of care single treatment for this application in the U.S., targeting an estimated total addressable market in this country of approximately $1bn.
“In doing so, our goal is to address this major unmet medical need for patients and surgeons, while establishing a new, potentially significant driver of future company growth.”
Currently, there are no approved alternatives in the US to reduce bleeding risks during cardiothoracic surgery, due to direct oral anticoagulants, the company said.
CytoSorbents claims that its DrugSorb-ATR system has the potential to address the major unmet medical needs, if granted marketing approvals in the US.
The STAR-D trial is designed to support FDA marketing approval of DrugSorb–ATR system, and its IDE approval follows the STAR-T trial for ticagrelor removal.
It is expected to enrol up to 120 patients across 25 US clinical sites, many of which are already being used for the STAR-T trial.
The study will be led by investigators Michael Mack and C Michael Gibson, along with an executive committee comprising cardiac surgeons, cardiologists, and thrombosis experts.