Patients on blood thinners can develop serious bleeding complications
*DrugSorb-ATR is an investigational device.1
Today, millions of people around the world are on antithrombotic drugs, more commonly known as blood thinners, to reduce their risk of heart attack and stroke.
Examples include blockbuster drugs like the direct oral anticoagulants (DOACs) Eliquis® and Xarelto®, anti-platelet drugs like Brilinta® and Plavix®, and direct thrombin inhibitors like Pradaxa®. However, if patients are unexpectedly hospitalized and require surgery, they run the risk of serious and potentially fatal perioperative bleeding due to the blood thinner.
Anti-platelet therapy
Heart attack patients in the hospital are often administered dual anti-platelet therapy, which includes both aspirin and a “super-aspirin” like Brilinta® (ticagrelor, AstraZeneca), to reduce the risk of major adverse cardiovascular events like worsened heart attack, stroke, or death.
Risk of perioperative bleeding
Although most heart attack patients will go on to receive a stent in the cardiac cath lab, up to 10% of patients will not be eligible for a stent and will require urgent or emergent coronary artery bypass graft (CABG) surgery to restore blood flow to the affected portion of the heart. However, having just received the blood thinner, these patients are at high risk of perioperative bleeding.
Clinical risk & additional costs
Waiting in the hospital to washout the drug over the span of 3-5 days is the only acceptable alternative. But given that the significant blockages in the coronary arteries remain untreated, waiting comes with potential clinical risk for another heart attack or other life-threatening complications like heart failure. In addition, waiting in-hospital for multiple days to get the needed operation adds significant additional costs and blocks beds desperately needed to treat other patients.
Completion of the pivotal U.S. and Canadian randomized, controlled STAR-T trial
The DrugSorb™-ATR antithrombotic removal system, an investigational device based on the same polymer technology as CytoSorb, has completed the pivotal, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal – ticagrelor) trial of 140 patients at approximately 30 centers in U.S. and Canada. The study evaluated whether intraoperative use of DrugSorb-ATR can reduce the perioperative bleeding risk of patients on ticagrelor who undergo cardiothoracic surgery within 2 days of the last dose of drug.
A Review of STAR-T Pivotal Trial Results & Real World Experience with Antithrombotic Drug Removal in Europe”
Watch the full video featuring Dr. Michael Mack, Dr. Michael Gibson, Dr. Richard Whitstock and Dr. Michael Schmöckel here.
Perioperative bleeding in cardiac surgery due to ticagrelor is a major unmet medical need
This is the reason why DrugSorb-ATR has been granted U.S. FDA Breakthrough Device Designation. There are currently no approved or cleared therapies for this unmet need in the U.S. or Canada.
Regulatory submissions to the U.S. FDA and Health Canada were made in September and November 2024
The DrugSorb-ATR De Novo application has been submitted to the U.S. FDA on September 27, 2024. FDA acceptance and initiation of substantive review of our application has been announced on October 22, 2024. DrugSorb ATR is eligible for priority review based on FDA Breakthrough Device Designation.
CytoSorbents has received the Medical Device Single Audit Program (MDSAP) certification on November 1, 2024, a key regulatory milestone that certifies compliance of the quality management system with the standard regulatory requirements of Canada, the U.S., Brazil, Japan, and Australia. Importantly, U.S. FDA accepts MDSAP certification and audit reports in lieu of their own routine Agency inspections, if required.
In addition, CytoSorbents has submitted the Medical Device License (MDL) marketing application to Health Canada on November 1, 2024, concurrent with MDSAP certification – a requirement for submission.
1. DrugSorb-ATR is an investigational device and has not been evaluated by, and is not yet cleared/approved by the FDA, Health Canada, or by any other global regulatory agency, and is not commercially available for sale.
Registered trademarks for Eliquis® (apixaban; Pfizer/BMS), Xarelto® (rivaroxaban; Bayer, Janssen/J&J), Brilinta® (AstraZeneca), Plavix® (BMS/Sanofi-aventis), and Pradaxa® (Boehringer Ingelheim) are owned by their respective manufacturers
