CytoSorbents Seeks Approval for DrugSorb-ATR in Canada to Reduce Bleeding in Heart Surgery
核心洞察
CytoSorbents has submitted a Medical Device License application to Health Canada for DrugSorb-ATR (搜索), targeting reduced bleeding during CABG surgery in patients on ticagrelor.
The application follows successful MDSAP certification, ensuring compliance with quality management system requirements in Canada and the U.S.
Regulatory decisions from Health Canada and the U.S. FDA are anticipated in 2025, potentially improving the standard of care for heart attack patients.
CytoSorbents Corporation has announced the submission of its DrugSorb™-ATR Medical Device License (MDL) application to Health Canada on November 1, 2024, coinciding with the receipt of its Medical Device Single Audit Program (MDSAP) certification. DrugSorb-ATR (搜索), an investigational medical device, aims to facilitate safe and timely coronary artery bypass graft (CABG) surgery in patients with acute coronary syndromes (搜索) (ACS) who are on the blood-thinning drug ticagrelor (Brilinta®, AstraZeneca). The Canadian MDL application follows the Company's DrugSorb-ATR U.S. Food and Drug Administration (FDA) De Novo filing, which is currently under substantive review.
Addressing a Critical Unmet Need
The use of ticagrelor, a blood-thinning agent, is common in heart attack patients. However, it poses a significant challenge when CABG surgery is required. Current guidelines recommend delaying surgery by three to five days to allow the drug to “washout” and reduce the risk of severe perioperative bleeding. DrugSorb-ATR (搜索) is designed to mitigate this risk by removing ticagrelor from the patient's blood, potentially enabling earlier and safer surgery.
Regulatory Pathway and Expectations
“We are excited to have now submitted DrugSorb-ATR (搜索) for marketing approval in both the U.S. and Canada,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. He added that the MDSAP certification is a key regulatory milestone, with the U.S. FDA accepting MDSAP certification and audit reports as a substitute for routine Agency inspections, if required. The company anticipates regulatory decisions in 2025, with Health Canada potentially preceding the FDA.
Clinical Evidence and Market Potential
The application is supported by data from the 140-patient North American pivotal STAR-T trial, a randomized, double-blind, sham-controlled study. This trial evaluated the safety and efficacy of DrugSorb-ATR (搜索) in patients undergoing urgent cardiac surgery on ticagrelor, comparing perioperative bleeding complications in patients treated with the device versus those operated on without it. According to Dr. Chan, a future Health Canada approval of DrugSorb-ATR has the potential to improve the standard of care in heart attack patients requiring CABG surgery by enabling safe and timely surgery while eliminating treatment delays that expose patients to additional risk and consume valuable hospital resources.
About CytoSorbents Corporation
CytoSorbents Corporation (NASDAQ: CTSO) is focused on blood purification technologies for critical care. Their proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. CytoSorb®, the company's lead product, is approved in the European Union and distributed in 76 countries worldwide, with over 250,000 devices used cumulatively to date. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures.