DOAC

Perosphere Technologies Adds Dr. Michael Grosso to Advisory Board

Retrieved on: 
월요일, 5월 20, 2024
Hospitals, Health Technology, Health, Medical Devices, Sanofi, Patient, Thrombosis, Ophthalmology, DOAC, University, FACS, Advisory board, Neurology, Daiichi Sankyo, Physician, Hematology, Inflammation, Anticoagulant, Pharmaceutical industry

Perosphere Technologies (Perosphere Technologies Inc.), a private medical technologies company focused on developing next-generation coagulation diagnostics, today announced Michael A. Grosso, MD, FACS, joins its Advisory Board.

Key Points: 
  • Perosphere Technologies (Perosphere Technologies Inc.), a private medical technologies company focused on developing next-generation coagulation diagnostics, today announced Michael A. Grosso, MD, FACS, joins its Advisory Board.
  • “We are thrilled to welcome Dr. Michael Grosso to Perosphere’s Advisory Board,” said Dr. Sasha Bakhru, CEO of Perosphere Technologies.
  • “The technology Perosphere is developing excites me both as a physician and as a leader in clinical development.
  • I am honored to have been asked to join the Advisory Board in order to support Perosphere’s great work,” said Dr. Grosso.

First-Ever Cost-Effectiveness Analysis of a Factor XI Inhibitor Demonstrates that Abelacimab, if Approved, Could Offer Significant Cost Savings as Compared to a Current Standard of Care Anticoagulant

Retrieved on: 
월요일, 5월 6, 2024
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, USD, Anticoagulant, Hemostasis, Stroke, TIMI, Anthos, Risk, DOAC, MD, Doctor of Philosophy, Pharmacist, AZALEA, Patient, Professional, Atrial fibrillation, Therapy, Life imprisonment, Thrombosis, Rivaroxaban, Pharmaceutical industry

Results of the first-ever cost-effectiveness study of a Factor XI inhibitor were presented today during sessions of the Professional Society for Health Economics and Outcomes Research (ISPOR) annual meeting.

Key Points: 
  • Results of the first-ever cost-effectiveness study of a Factor XI inhibitor were presented today during sessions of the Professional Society for Health Economics and Outcomes Research (ISPOR) annual meeting.
  • The analysis indicates that abelacimab could offer a potential cost-savings of $50,000 USD and improvements of 1.5 quality-adjusted life years (QALY’s) per person over a lifetime horizon as compared to rivaroxaban, a commonly used direct oral anticoagulant (DOAC).
  • If approved by US regulatory authorities, abelacimab could be a highly cost-effective anticoagulant option.
  • The great promise of a factor XI inhibitor such as abelacimab, rests largely with the ability to prevent thrombosis with minimal disruption of hemostasis.

Anthos Therapeutics' Novel Dual-Acting Factor XI/XIa Inhibitor, Abelacimab 150 mg, Demonstrated a 67% Reduction in the Primary Endpoint of Major or Clinically Relevant Non-Major Bleeding Compared with Rivaroxaban in Patients with Atrial Fibrillation

Retrieved on: 
일요일, 11월 12, 2023
Biotechnology, Surgery, Health, Pharmaceutical, Clinical Trials, Ruff, Harvard University, Atrial fibrillation, Arrhythmia, Associate, Safety, Therapy, MIT, Factor XI, Risk, AHA, Multimedia, Anticoagulant, Stroke, Heart failure, American Heart Association, Thrombosis, DOAC, Hemostasis, Bleeding, Harvard Medical School, MPH, CDC, Hospital, Ventricular fibrillation, Pharmaceutical industry, Rivaroxaban, Medicine, MD, Brigham, Patient

Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.

Key Points: 
  • Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.
  • Although currently available anticoagulants are effective in preventing strokes in patients with atrial fibrillation, the risk of bleeding remains an issue.
  • “Based on the evidence to date, we are highly confident that abelacimab will offer a potential game-changing treatment approach for patients with atrial fibrillation."
  • Abelacimab is an investigational agent and is not approved for any indication in any country.

FloBio Receives FDA's Breakthrough Device Designation for Bleeding Risk Diagnostic Test

Retrieved on: 
화요일, 10월 17, 2023
Diagnosis, Nursing care plan, Hospital, Food, Death, Stroke, DOAC, Mortality, Atrial fibrillation, Patient, FDA, Trauma, Anticoagulant, Regulation of tobacco by the U.S. Food and Drug Administration, Deep vein thrombosis, Emergency, Face, Physician, Birth control, Medical device

PHILADELPHIA, Oct. 17, 2023 /PRNewswire/ -- FloBio, a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. FloBio's test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs). This information would help emergency and critical care clinicians make informed treatment decisions about drug reversal to reduce serious bleeding, a major cause of preventable complications and death in US hospitals.

Key Points: 
  • PHILADELPHIA, Oct. 17, 2023 /PRNewswire/ -- FloBio , a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test.
  • The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
  • FloBio's test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs).
  • This makes it difficult to  adequately prevent or manage bleeding in the face of trauma, invasive surgeries, stroke, and other medical conditions.

CytoSorbents Highlights Upcoming Presentations at EACTS 2023: Focus on Antithrombotic Removal including the 2nd Analysis of the International STAR Registry

Retrieved on: 
수요일, 9월 27, 2023
CABG, Percutaneous coronary intervention, Anticoagulant, International, Bleeding, Intraparenchymal hemorrhage, CET, Boehringer, Dabigatran, STAR, EACTS, Edoxaban, Acute coronary syndrome, International Star Registry, Cytokine adsorbing column, CTD, Research, AstraZeneca, Professional corporation, Eli Lilly, Clopidogrel, DOAC, Boehringer Ingelheim, Incidence, Bayer, Neurosurgery, International Safe Harbor Privacy Principles, Patient, Risk, European Heart Journal, Daiichi Sankyo, Blood, Rivaroxaban, Annual general meeting, Cytosorbents Corporation, United Kingdom, BMS, Cardiology, European Association for Cardio-Thoracic Surgery, Starship Enterprise, Trauma, Ticagrelor, ATR, Pfizer, Birth control, Pharmaceutical industry, Dentistry, Janssen, Aorta, Sanofi

The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) in the acute hospital setting.

Key Points: 
  • The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) in the acute hospital setting.
  • The STAR Registry, not to be confused with the completed U.S. and Canada STAR-T pivotal trial, is enrolling ahead of internal projections with plans for ongoing presentations at large, international conferences.
  • The first registry analysis entitled, “ Insights from the International Safe and Timely Antithrombotic Removal (STAR) Registry ” was presented at the EuroPCR conference in May 2023, the largest interventional cardiology conference in the E.U., attracting 11,500+ participants this year.
  • It also includes, for the first time, data on patients being treated with CytoSorb to reduce seven different antithrombotic medications.

Atrial Fibrillation Study with Abelacimab Stopped Early by the Data Monitoring Committee Due to an Overwhelming Reduction in Bleeding as Compared to a DOAC (Direct Oral Anticoagulant)

Retrieved on: 
월요일, 9월 18, 2023
Research, General Health, Pharmaceutical, Oncology, Clinical Trials, Science, Surgery, Cardiology, Biotechnology, FDA, Other Science, Health, VTE, Bleeding, Factor XI, National Blood Clot Alliance, Medicine, Atrial fibrillation, Data monitoring committee, The New England Journal of Medicine, Stroke, Xi, DOAC, Harvard Medical School, CDC, Thrombosis, Anticoagulant, Gold, Coronary thrombosis, Patient, Myocardial infarction, Risk, Rivaroxaban, Thrombolysis, TIMI, Pravastatin or atorvastatin evaluation and infection therapy - thrombolysis in myocardial infarction 22, Hospital, Congress, MPH, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Centers for Disease Control and Prevention, Pharmaceutical industry, Brigham, MD

The study has been stopped early by the Data Monitoring Committee due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban, a leading standard-of-care DOAC.

Key Points: 
  • The study has been stopped early by the Data Monitoring Committee due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban, a leading standard-of-care DOAC.
  • In addition, abelacimab is the first and only Factor XI inhibitor to demonstrate an unprecedented reduction in major bleeding compared to a DOAC, which is the most serious type of bleeding.
  • “The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant.
  • Abelacimab 150 mg maintains ~98% inhibition over the dosing interval, recapitulating the benign bleeding profile of patients with genetic Factor XI deficiency.

Now available from Aniara Diagnostica DP-Filter® For Removal of DOACs from Plasma Specimens

Retrieved on: 
목요일, 8월 24, 2023
Anticoagulant, Use, WEST, Dabigatran, Edoxaban, Multimedia, DOAC, Apixaban, Plasma, DP, Diagnosis, Rivaroxaban, Filtration, Research

WEST CHESTER, Ohio, Aug. 24, 2023 /PRNewswire-PRWeb/ -- Aniara Diagnostica, a multi-national distributor of diagnostic and research agents, as well as screening tools, has strengthened its commitment to meeting today's highest standards for product quality and cost-efficient delivery.

Key Points: 
  • WEST CHESTER, Ohio, Aug. 24, 2023 /PRNewswire-PRWeb/ -- Aniara Diagnostica, a multi-national distributor of diagnostic and research agents, as well as screening tools, has strengthened its commitment to meeting today's highest standards for product quality and cost-efficient delivery.
  • The study of blood samples containing DOACs is challenging and may lead to false results.
  • The DP-Filter® is effective in filtering DOAC from citrated plasma providing anticoagulant-free plasma that can be used for testing.
  • The entire Aniara product line is available for purchase at http://www.aniara.com .

Data at Heart Rhythm 2023 Highlight Key Boston Scientific Therapies

Retrieved on: 
토요일, 5월 20, 2023
Tricuspid valve, Heart Rhythm Society, EU, Freedom, Chosen-ciphertext attack, Heart failure, Pulmonary vein stenosis, Boston Scientific, BSX, Atrial fibrillation, Learning curve, FLX, ICD, NCDR, Catheter ablation, Arrhythmia, DOAC, Atrial tachycardia, Kaplan–Meier estimator, Heart Rhythm, Patient, Molina Healthcare, Physician, Electrophysiology, Data, Risk, LAAC, Diagnosis, Growth, AF, IDE, Ventricular fibrillation, Recurrence, Cardiology, NYSE, Disease, Safety, Journal of the American College of Cardiology, ATLAS, Medical imaging, Pharmaceutical industry, Nursing, Birth control, Medical device

MARLBOROUGH, Mass., May 20, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced data supporting use of the company's key electrophysiology and cardiac rhythm management therapies, and the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. All data were presented at Heart Rhythm 2023, the annual meeting of the Heart Rhythm Society, held in New Orleans from May 19-21.

Key Points: 
  • All data were presented at Heart Rhythm 2023, the annual meeting of the Heart Rhythm Society, held in New Orleans from May 19-21.
  • The registry data included favorable single procedure success rates, along with efficient procedure times in a broad patient population.
  • Data demonstrated a predictable workflow with a median of 58 minutes within an interquartile range of 40 to 87 minutes.
  • "The data shared at this year's Heart Rhythm meeting showcases the breadth and depth of our cardiology therapies, which spans from diagnosis to treatment of cardiac disease, and highlights the continued growth of our portfolio," said Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific.

Best Poster Awardees Announced at AMCP 2023 Focus on Adherence

Retrieved on: 
금요일, 4월 7, 2023
Anticoagulant, Medicine, CAE, Doctor of Pharmacy, University, Atrial fibrillation, Evidence-based medicine, AMCP, Master of Philosophy, Health, MBA, Research, Doctor of Philosophy, DOAC, Medicare, Graduate, PDC, DSM-IV codes, MDD, Patient, Population health, University of Houston, Prevalence, Jefferson College, Ageing, CVS Health, Medication, Female, Major depressive disorder, Nursing

ALEXANDRIA, Va., April 7, 2023 /PRNewswire/ -- AMCP Foundation and CVS Health announced the recipients of AMCP Foundation's Best Poster Awards at AMCP 2023.

Key Points: 
  • ALEXANDRIA, Va., April 7, 2023 /PRNewswire/ -- AMCP Foundation and CVS Health announced the recipients of AMCP Foundation's Best Poster Awards at AMCP 2023.
  • Since 2002, AMCP Foundation's Best Poster Competition has allowed student pharmacists and new practitioners to demonstrate analytic proficiency, poster development, and technical skills.
  • AMCP Foundation also periodically invites established researchers to compete for topical Best Poster Awards.
  • The Best Poster Awards at AMCP 2023 were made possible by funding partner CVS Health, the Journal of Managed Care & Specialty Pharmacy, the Best Poster judges, and research preceptors who support AMCP Foundation's efforts to recognize future pharmacists and new practitioners conducting transformative research.

CytoSorbents Appoints Irina B. Kulinets, PhD, as Senior Vice President of Global Regulatory Affairs

Retrieved on: 
화요일, 1월 17, 2023
Trident, Cytosorbents Corporation, Professional corporation, Mechanical engineering, RAPS, Cynosure, SVP, RAC, Quality, Boston Scientific, Clinical research, Medicine, Bleeding, Self-signed certificate, FDA, Risk, Johnson & Johnson, Medical Affairs Bureau, Master, Regulatory affairs, California State University, Terumo, Marketing, Elective surgery, Patient, ATR, Biosphere, DOAC, NextGen Healthcare, PMA, Faculty, Cytokine adsorbing column, Northeastern University, Medical device, Pharmaceutical industry, Georgetown University, Science

PRINCETON, N.J., Jan. 17, 2023 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has appointed Irina B. Kulinets, Ph.D., as Senior Vice President of Global Regulatory Affairs.  Dr. Kulinets brings more than 30 years of experience in regulatory affairs and clinical research of medical devices, biologics, and combination products in multiple therapeutic areas, including cardiovascular, neurovascular, oncology, orthopedics, biologic implants, and others.  She will serve as a member of CytoSorbents' executive management team and will report to Vincent Capponi, President and Chief Operating Officer of CytoSorbents.

Key Points: 
  • She will serve as a member of CytoSorbents' executive management team and will report to Vincent Capponi, President and Chief Operating Officer of CytoSorbents.
  • Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents
    Dr. Kulinets was most recently the SVP of Regulatory Affairs, Clinical Research, and Quality at MicroVention, Inc. , a division of Terumo Corporation and a global manufacturer of neuroendovascular medical devices.
  • Mr. Vincent Capponi remarked, "I am excited that Irina is joining the CytoSorbents team to lead Global Regulatory Affairs.
  • She is RAPS (Regulatory Affairs Professionals Society) certified RAC (Regulatory Affairs Certification) and Board Certified in Medical Affairs.