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FDA grants Breakthrough Device designation for Pharma’s System to reduce risk of serious bleeding during urgent cardiothoracic surgery

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https://seekingalpha.com/news/37294...eakthrough-device-tag-for-drugsorb-atr-system

CytoSorbents stock jumps 18% on second FDA Breakthrough Device tag for DrugSorb-ATR system​

Aug. 12, 2021 7:30 AM ETCytosorbents

  • CytoSorbents (NASDAQ:CTSO) soars 18% premarket in reaction to the announcement that FDA has granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System.
  • 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.
 
  • The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application.
  • "The U.S. STAR-T (Safe and Timely Antithrombotic Removal - Ticagrelor) pivotal randomized, 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," stated Mr. Vincent Capponi, President and Chief Operating Officer.
 
https://www.prnewswire.com/news-rel...-urgent-cardiothoracic-surgery-301354007.html

Second U.S. FDA Breakthrough Device Designation Granted to CytoSorbents' DrugSorb-ATR™ Antithrombotic Removal System Adding the Removal of Market-Leading Direct Oral Anticoagulants During Urgent Cardiothoracic Surgery​

FDA Breakthrough Designation Granted to CytoSorbents' DrugSorb-ATR for Removal of Apixaban and Rivaroxaban to Reduce the Risk of Serious Bleeding in Urgent Cardiothoracic Surgery
 
MONMOUTH JUNCTION, N.J., Aug. 12, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Company has been granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System by the U.S. 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.
 
Dr. David Cox, Vice President of Global Regulatory Affairs of CytoSorbents remarked, "The U.S. 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 recognized 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."
 
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, "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 U.S. strategy to potentially establish DrugSorb-ATR as an easy-to-implement, new standard of care to remove antithrombotic drugs during cardiothoracic surgery. The U.S. STAR-T (Safe and Timely Antithrombotic Removal - Ticagrelor) pivotal randomized, 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 $500 million in the U.S. alone today, which is expected to significantly increase based on prescribing trends and generic availability of these drugs."

Apixaban (Eliquis®, Bristol Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Jansen/Johnson & Johnson) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients1 annually in the United States who are chronically on these medications to reduce the risk of deadly blood clots due to atrial fibrillation, prior history of heart attack or stroke, deep vein thrombosis, pulmonary embolism, and peripheral artery disease. We expect the number of patients prescribed these drugs to continue to climb based on the superior performance of these agents compared to older alternatives, underlying demographic trends in the aging baby boomer population, improved disease detection rates, and other factors. When patients on various "blood thinners", like apixaban or rivaroxaban, require urgent cardiothoracic surgery, the risk of serious or life-threatening bleeding and complications is very high. Based on our estimates, at least 1% of patients in the U.S. on apixaban or rivaroxaban may require urgent cardiothoracic surgery on an annual basis. Today there are no approved or cleared alternatives in the U.S. to reduce bleeding risks during cardiothoracic surgery caused by direct oral anticoagulants. DrugSorb-ATR has the potential to address this major unmet medical need.
 
About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 143,000 CytoSorb devices have been delivered to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorizationin the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure. CytoSorbents' technology has also been granted FDA Breakthrough Designation for the removal of ticagrelor, rivaroxaban, and apixaban in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery, and if FDA marketing approval is obtained, would be marketed as DrugSorb-ATR™ in the United States.

CytoSorbents' 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. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
 
MONMOUTH JUNCTION, N.J., Aug. 12, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology
https://www.fda.gov/medical-devices...dical-devices/blood-purification-devices-euas

  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Blood Purification Devices EUAs​


Blood purification devices may be effective at treating certain patients with confirmed COVID-19 by reducing various pathogens, cytokines, and other inflammatory mediators, that is, small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that may occur in some COVID-19 patients, potentially leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
The table below lists the authorization information for the use of specific blood purification devices during the COVID-19 public health emergency.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
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Nobody is interested in your dots, nobody comments, nobody gives a fuck. You trash slut.
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Instead of rubbish seen by you @glockman clone Jeremy Quek self proclaimed judge, I see only connecting dots. Nothing i post is rubbish, not like you post all rubbish, filth and toxic lies of me. Pui!
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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.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5613602/

Cardiopulmonary bypass (CPB) provides a bloodless field for cardiac surgery. It incorporates an extracorporeal circuit to provide physiological support in which venous blood is drained to a reservoir, oxygenated and sent back to the body using a pump. Team effort between surgeon, perfusionist and anaesthesiologist is paramount for the successful use of CPB. However, it also has its share of complications and strategies to reduce these complications are the area of the current research.
 
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