CytoSorbents Gets FDA’s IDE Approval to Begin Trial of Antithrombotic Removal System

CytoSorbents has received the FDA’s approval of its Investigational Device Exemption (IDE) application, allowing it to conduct a pivotal clinical trial of its DrugSorb-ATR antithrombotic removal (ATR) system.

The DrugSorb-ATR system has also received the FDA’s Breakthrough Device designation, which will continue to apply as the trial progresses, the New Jersey-based company said.

The system is intended to remove Bristol-Myers Squibb’s and Pfizer’s Eliquis (apixaban) or Janssen’s and Bayer’s Xarelto (rivaroxaban) from a cardiopulmonary bypass circuit to reduce the risk of serious perioperative bleeding during cardiothoracic surgery. The double-blind, randomized, controlled trial, dubbed STAR–D (safe and timely antithrombotic removal — direct oral anticoagulants), will be conducted in the U.S.