Anticoagulant

Conformal Medical to Present One-Year Data from its Left Atrial Appendage Occlusion (LAAO) Early Feasibility Study at TCT 2023

Retrieved on: 
torsdag, oktober 19, 2023
Stroke, Medical research, Atrial fibrillation, Ventricular fibrillation, Lankenau Institute for Medical Research, Structure, Conformal, Health, CLAAS, TEE, Anticoagulant, LAA, Risk, EFS, Safety, TCT, Patient, Main Line Health, Medical device

NASHUA, N.H., Oct. 19, 2023 /PRNewswire/ -- Conformal Medical, Inc. announced today the one-year results from the company's CONFORMAL Early Feasibility Study (EFS) will be presented during the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, CA. Dr. William Gray, System Chief, Cardiovascular Diseases at Main Line Health and professor at Lankenau Institute for Medical Research will present, "Conformal CLAAS LAAO Device EFS 1-Year TEE Follow Up" during a moderated abstract session.

Key Points: 
  • "I look forward to presenting the much anticipated one-year TEE follow up data from our initial clinical experience," stated Dr. Gray.
  • "We are extremely pleased to have the one-year Conformal EFS data presented at this year's TCT conference," commented James Reinstein, CEO of Conformal Medical.
  • Conformal Medical is currently enrolling patients in its CONFORM Pivotal Trial to support U.S. commercialization.
  • Wednesday, October 25th - Conformal Medical to host a breakfast symposium, "CLAAS Act: Conformal Medical Overview and CONFORM Trial Update" at 6:30am PT in Presentation Theater 1.

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

Retrieved on: 
tisdag, oktober 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.

Elixir Medical To Present Randomized Clinical Dataset Featuring World’s First Triple Drug-Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus at TCT 2023

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torsdag, oktober 5, 2023
Science, Cardiology, Biotechnology, Research, Health, Medical Devices, Health Technology, Clinical Trials, Elixir, Exhibition, Death, Medicine, Innovation, Coronary artery disease, DAPT, Risk, Moscone Center, PCI, Anticoagulant, Percutaneous coronary intervention, Data collection, Abstract (summary), Novel, OCT, Clinical study design, Automotive Supplier Innovation Program, Sirolimus, Rivaroxaban, Patient, RCT, Diagnosis, TCT, Pharmaceutical industry, Fine chemical

The data compare DESyne BDS Plus, the world’s first triple drug-eluting stent with local anticoagulation delivery technology using two anticoagulants (rivaroxaban and argatroban) and an anti-proliferative mTOR inhibitor (sirolimus) to a second-generation durable polymer DES.

Key Points: 
  • The data compare DESyne BDS Plus, the world’s first triple drug-eluting stent with local anticoagulation delivery technology using two anticoagulants (rivaroxaban and argatroban) and an anti-proliferative mTOR inhibitor (sirolimus) to a second-generation durable polymer DES.
  • “Stent thrombosis after percutaneous coronary intervention (PCI), though rare, is a severe complication with death or heart attack risk of up to 50% after the event.
  • An imaging subset of 60 patients had angiographic and optical coherence tomography (OCT) assessment completed at six months.
  • Elixir Medical is also hosting the scientific symposium, “Innovation for PCI: Improved outcomes require disruption” featuring a panel of speakers including Robert W. Yeh, M.D., Mirvat Alasnag, M.D, Ignacio Cruz-Gonzalez, M.D., Ph.D., Roxana Mehran, M.D.

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

Retrieved on: 
onsdag, september 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.

Study Confirming Overwhelming Reduction in Bleeding of the Dual-Acting Factor XI/XIa Inhibitor Abelacimab as Compared to Rivaroxaban Selected as Late-Breaker Oral Presentation at the American Heart Association Scientific Sessions

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tisdag, september 26, 2023
Cardiology, Biotechnology, Pharmaceutical, Surgery, Oncology, Health, FDA, Clinical Trials, Ruff, Bleeding, American Heart Association, Atrial fibrillation, Stroke, MIT, Harvard University, Associate, Harvard Medical School, Thrombosis, Anticoagulant, Hemostasis, Patient, Physician, Rivaroxaban, Hospital, Data monitoring committee, Therapy, MPH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, News, DMC, Food, Pharmaceutical industry, Brigham, MD, Medicine

This news comes just days after it was announced that the AZALEA-TIMI 71 study was stopped early by the independent Data Monitoring Committee (DMC) due to an overwhelming greater-than-anticipated reduction in major and clinically relevant non-major bleeds in abelacimab compared to rivaroxaban and a benefit/risk profile also favoring abelacimab.

Key Points: 
  • This news comes just days after it was announced that the AZALEA-TIMI 71 study was stopped early by the independent Data Monitoring Committee (DMC) due to an overwhelming greater-than-anticipated reduction in major and clinically relevant non-major bleeds in abelacimab compared to rivaroxaban and a benefit/risk profile also favoring abelacimab.
  • A Fast-Track Designation for abelacimab was previously granted by the U.S. Food and Drug Administration (FDA) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
  • “This additional positive news further recognizes the confidence that Anthos Therapeutics placed early-on in the development program of abelacimab.
  • The results of the AZALEA-TIMI 71 study firmly establishes that thrombosis can successfully be uncoupled from hemostasis,” said John Glasspool, CEO, Anthos Therapeutics.

LEQEMBI® Intravenous Infusion (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan

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måndag, september 25, 2023
Hypersensitivity, Status epilepticus, Intracerebral hemorrhage, Cerebral amyloid angiopathy, Arthralgia, Cerebral edema, Hypotension, Aneurysm, Risk, Focal neurologic signs, Chills, Fatal, Fever, Edema, Neuroimaging, AND, Angioedema, Siderosis, Tissue plasminogen activator, Aspirin, Hypertension, Vomiting, Incidence, Excipient, ARIA, Anticoagulant, MRI, Magnetic resonance imaging, Dizziness, Amyloid, Patient, Intraparenchymal hemorrhage, Anaphylaxis, Paracetamol, Seizure, Genetic testing, Confusion, Nausea, Observation, Lecanemab, Headache, Bronchospasm, Vascular malformation, Medical device, Pharmaceutical industry, Lace, Medical imaging, Copper

INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.

Key Points: 
  • INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.
    LEQEMBI is indicated for the treatment of Alzheimer’s disease.
  • Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
  • ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Memphis Seniors with a History of Atrial Fibrillation Joining New Research Study

Retrieved on: 
onsdag, september 20, 2023
Men, Research, Other Health, Pharmaceutical, Consumer, Clinical Trials, Science, Cardiology, Biotechnology, Women, Seniors, FDA, Health, Bleeding, Stroke, Atrial fibrillation, Hope, Multimedia, History, Health care access among Dalits in India, Incidence, Anticoagulant, Patient, Physician, Risk, Kidney, Therapy, Safety, Pharmaceutical industry, Ventricular fibrillation

A global research study is now available in Memphis, Tenn., for an investigational medication that may help patients with a history of atrial fibrillation (AFib) decrease their risk of stroke.

Key Points: 
  • A global research study is now available in Memphis, Tenn., for an investigational medication that may help patients with a history of atrial fibrillation (AFib) decrease their risk of stroke.
  • “Atrial fibrillation is a common issue in older adults and significantly impacts our seniors here in Memphis,” said Dr. Joseph Weinstein, Principal Investigator at Care Access - Memphis.
  • Care Access opened its Memphis location in collaboration with local community leaders and healthcare providers seeking to make clinical research more accessible to local residents.
  • With a global network of over 150 research sites, Care Access supports research studies conducted by 14 of the top 20 biopharmaceutical companies.

Tamarac Seniors Diagnosed with Atrial Fibrillation Join Innovative Research Study

Retrieved on: 
onsdag, september 20, 2023
Other Health, Research, Pharmaceutical, Consumer, Clinical Trials, Science, Cardiology, Biotechnology, Seniors, FDA, Other Science, Health, Bleeding, Prevalence, Stroke, Atrial fibrillation, Hope, Multimedia, History, Health care access among Dalits in India, Incidence, Anticoagulant, Patient, Physician, Risk, Kidney, Diagnosis, Safety, Pharmaceutical industry, Nursing, Ventricular fibrillation

A global research study is now available in Tamarac, Fla., for an investigational treatment to help patients with a history of atrial fibrillation (AFib) decrease their risk of stroke.

Key Points: 
  • A global research study is now available in Tamarac, Fla., for an investigational treatment to help patients with a history of atrial fibrillation (AFib) decrease their risk of stroke.
  • Patients with AFib are known to have a four to five times higher risk of stroke than the general population.
  • Care Access opened its Tamarac location in collaboration with local community leaders and healthcare providers seeking to make clinical research more accessible to South Florida residents.
  • With a global network of over 150 research sites, Care Access supports research studies conducted by 14 of the top 20 biopharmaceutical companies.

Alarming Increase in Cardiovascular Disorders Propels Growth in the 2023 Global Atherosclerosis Drugs Market - ResearchAndMarkets.com

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måndag, september 18, 2023
Pharmaceutical, Health, Cardiology, Blood pressure, Plaque, Obesity, Coronary artery disease, Pharmacy, Atherosclerosis, Splenic infarction, Market, Research, Artery, Inflammation, Aspirin, Peripheral artery disease, Government, Administration, Anticoagulant, Investment, Patient, Risk, ACE, Distribution, Route of administration, Growth, Diagnosis, R, Thrombus, Pharmaceutical industry

The global atherosclerosis drugs market, valued at $20.60 billion in 2022, is poised for substantial growth and is estimated to reach $27.71 billion by 2032, with a compound annual growth rate (CAGR) of 3% from 2023 to 2032.

Key Points: 
  • The global atherosclerosis drugs market, valued at $20.60 billion in 2022, is poised for substantial growth and is estimated to reach $27.71 billion by 2032, with a compound annual growth rate (CAGR) of 3% from 2023 to 2032.
  • Atherosclerosis drugs play a vital role in reducing plaque formation, managing cholesterol levels, reducing inflammation, preventing blood clots, and improving blood flow.
  • The growth of the global atherosclerosis drugs market is primarily driven by the alarming increase in cardiovascular disorders.
  • Additionally, the rising awareness of early diagnosis and treatment of atherosclerosis is boosting the demand for these drugs, positively impacting market growth.

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: 
måndag, september 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.