Hemostasis

Dimension Inx Announces First Surgical Cases Utilizing CMFlex™ Synthetic Bone Graft - The First 3D-printed Regenerative Bone Graft Product Cleared by the FDA

Retrieved on: 
Wednesday, October 4, 2023
Technology strategy, Surgeon, Therapy, CSO, 3D, North Carolina Center for the Advancement of Teaching, History, Chemistry, Hemostasis, Yale New Haven Health System, Science Translational Medicine, Bone remodeling, Biology, FDA, INX, PLG, Pharmaceutical industry, Dentistry, Oral and maxillofacial surgery, MD, DDS

CHICAGO, Oct. 4, 2023 /PRNewswire/ -- Dimension Inx , a biomaterials platform company, today announced that CMFlex™, the first 3D-printed regenerative bone graft product with FDA approval, has been successfully used in its first clinical cases.

Key Points: 
  • CHICAGO, Oct. 4, 2023 /PRNewswire/ -- Dimension Inx , a biomaterials platform company, today announced that CMFlex™, the first 3D-printed regenerative bone graft product with FDA approval, has been successfully used in its first clinical cases.
  • CMFlex is a 3D-printed synthetic bone graft used for various bony defects in oral and maxillofacial surgical applications.
  • Dimension Inx combines these base materials into a proprietary, microstructurally porous composite material, Hyperelastic Bone®, as first published in Science Translational Medicine in 2016.
  • CMFlex is currently available to a limited number of key surgeons with a broader release to follow later in 2024.

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

Retrieved on: 
Tuesday, 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.

Global Hemostasis Tests Market Predicts Robust Growth Until 2033: Prothrombin and Activated Prothrombin Tests in the Spotlight - ResearchAndMarkets.com

Retrieved on: 
Monday, September 25, 2023
Surgery, Health, Medical Devices, Acenocoumarol, ASP, Forecast, Internet, COVID-19, Partial thromboplastin time, Segment, Preoperative care, Warfarin, Market, SWOT, Patient, Microsoft Excel, Medtech, Phenprocoumon, SWOT analysis, Growth, Hemostasis, Retail, Medical device, Health insurance

The global hemostasis tests market is experiencing notable trends and developments in the field of in vitro diagnostics.

Key Points: 
  • The global hemostasis tests market is experiencing notable trends and developments in the field of in vitro diagnostics.
  • The impact of COVID-19 on the hemostasis tests market in 2020 and beyond has been carefully assessed.
  • Prothrombin (PT) and Activated Prothrombin (aPTT) tests are among the most widely used hemostasis tests.
  • The Hemostasis Tests market encompasses a range of tests, including:
    The market model offers comprehensive insights, including epidemiology-based indications with procedure volumes.

NovaBone's New Bioactive Glass Syringe for Foot & Ankle

Retrieved on: 
Monday, September 18, 2023
Ankle, Surgeon, Foot, Putty, Marketing, Bioactive glass, Hemostasis, Patient, Glass, FDA, Paediatric-use marketing authorisation

ALACHUA, Fla., Sept. 18, 2023 /PRNewswire-PRWeb/ -- NovaBone Products, leader in synthetic biologics, is pleased to announce the company has made commercially available a new syringe for targeted delivery of its 45S5 bioactive glass putty device for the foot and ankle market. The newly launched syringe comes in both a 2.5cc and a 5cc formulation.

Key Points: 
  • NovaBone Products launches a first foot and ankle-specific syringe delivery system for its bioactive glass delivery system.
  • ALACHUA, Fla., Sept. 18, 2023 /PRNewswire-PRWeb/ -- NovaBone Products, leader in synthetic biologics, is pleased to announce the company has made commercially available a new syringe for targeted delivery of its 45S5 bioactive glass putty device for the foot and ankle market.
  • "We are excited to provide our foot and ankle surgeons with a specific solution to deliver our best-in-class synthetic putty to their patients.
  • Dr. Charles E. Cook of Dallas, Texas, was the first foot and ankle surgeon to use the new product designed for medical use of bioactive glass.

Precision BioLogic's Factor VIII Deficient Plasma with VWF Now FDA-Cleared for Sale in U.S.

Retrieved on: 
Monday, September 18, 2023
Factor VIII, Haemophilia, Research, Biologic, ISTH, Von Willebrand factor, Plasma, VWF, Traction, Hemostasis, VIII, FDA, Vaccine, EU, NS

The latest in Precision BioLogic's family of factor deficient plasmas, CRYOcheck Factor VIII Deficient Plasma with VWF is intended for use in clinical laboratories to identify factor VIII (FVIII) deficiency in human plasma and aid in the management of hemophilia A.

Key Points: 
  • The latest in Precision BioLogic's family of factor deficient plasmas, CRYOcheck Factor VIII Deficient Plasma with VWF is intended for use in clinical laboratories to identify factor VIII (FVIII) deficiency in human plasma and aid in the management of hemophilia A.
  • CRYOcheck Factor VIII Deficient Plasma with VWF comes in a convenient frozen format, which eliminates reconstitution errors and reduces preparation time.
  • CRYOcheck Factor VIII Deficient Plasma with VWF launched in Canada, the EU, UK, Australia and New Zealand in 2021.
  • "CRYOcheck Factor VIII Deficient Plasma with VWF offers labs a readily available and reliable alternative to congenital FVIII deficient plasmas.

BioMarin to Present Pipeline at Upcoming R&D Day on Tuesday, September 12th

Retrieved on: 
Wednesday, September 6, 2023
Medical genetics, FRCP, University, Royal Free Hospital, University of the Witwatersrand, BioMarin Pharmaceutical, Consultant, Keck School of Medicine of USC, Achondroplasia, Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, National Health Laboratory Service, Charlotte Maxeke Johannesburg Academic Hospital, University of Southern California, BMRN, Division, University of Minnesota Medical School, SAN, NHS foundation trust, Evelina London Children's Hospital, Hospital, Haemophilia, Master of Medicine, Hemostasis, Broadcasting, Instrumentation, Pediatrics, Bachelor of Medicine, Bachelor of Surgery, Endocrinology

SAN RAFAEL, Calif., Sept. 6, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, will host an R&D Day at 8:00 a.m. ET on Tuesday, September 12, 2023. BioMarin management and external experts will provide an update to the investment community on the company's development portfolio.

Key Points: 
  • R&D Day to be Webcast Beginning at 8:00 a.m. Eastern Time September 12th
    SAN RAFAEL, Calif., Sept. 6, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, will host an R&D Day at 8:00 a.m.
  • ET on Tuesday, September 12, 2023.
  • BioMarin management and external experts will provide an update to the investment community on the company's development portfolio.
  • An archived version of the remarks will also be available through the Company's website for a limited time following the event.

Haemonetics Announces European Expansion for VASCADE® Vascular Closure System

Retrieved on: 
Tuesday, August 29, 2023
CE, EU, International, Gleneagles Global Hospitals, HAE, Back pain, Jewish Hospital (Cincinnati, Ohio), Hospital, Hemostasis, Cardiac catheterization, Medical director, Patient, Physician, Cardiology, EP, Haemonetics, MVP, European Medical Students' Association, NYSE, Pharmaceutical industry, Medical imaging, Electrophysiology

This marks the first use of the VASCADE system portfolio, widely used in U.S. hospitals, in a European country.

Key Points: 
  • This marks the first use of the VASCADE system portfolio, widely used in U.S. hospitals, in a European country.
  • The VASCADE system is designed for "small-bore" femoral arterial and venous closure, generally used in interventional cardiology and peripheral vascular procedures.
  • The VASCADE MVP system is designed for "mid-bore" multi-access femoral venous closure, generally used in electrophysiology procedures.
  • Haemonetics is planning further expansion for the VASCADE system portfolio in other markets outside the U.S.

Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+™ Hemostatic Device Usage in Cardiac Surgical Procedures

Retrieved on: 
Tuesday, August 1, 2023
Video-assisted thoracoscopic surgery, Bleeding, Regulation of tobacco by the U.S. Food and Drug Administration, TFX, The Journal of Thoracic and Cardiovascular Surgery, Elective surgery, Journal, Hemostasis, Patient, IDE, FDA, NYSE, Safety, Medical device, Dentistry, Teleflex, Anesthesia, QuikClot

This allows clinicians to use the QuikClot Control+™ Device to control all bleeding in cardiac surgical procedures.

Key Points: 
  • This allows clinicians to use the QuikClot Control+™ Device to control all bleeding in cardiac surgical procedures.
  • The expanded indications enable device utilization across a wider patient population and breadth of surgical procedures.
  • The QuikClot Control+™ Hemostatic Device also received expanded intended uses to include use with patients on anticoagulation/antiplatelet medication, use with or without autotransfusion (blood salvage) equipment, and use with or without cardiopulmonary bypass systems.
  • “We look forward to supporting positive patient outcomes in these procedures through the expanded use potential of our QuikClot Control+™ Devices.”

Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, July 26, 2023
Embolism, Factor IX, Bleeding, Health, Prothrombin time, Factor X, Stroke, Food and Drug Administration, Clinical trial, Thrombophilia, VKA, Octapharma, PCC, INR, Coagulation, Warfarin, Hemostasis, Patient, Protein C, Risk, Physician, Coagulation factor VII, Vitamin K, Trial of the century, Phase, FDA, Thrombin, Food, Safety, Pharmaceutical industry, Medical imaging

Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.

Key Points: 
  • Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.
  • The Phase III, randomized, double-blind, multicenter study was performed at 24 sites in the U.S. and Europe and randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103).
  • We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients' coagulation."
  • Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro ®.

Visualizing Quantitative Market Trends in Wound Care Management: Key Growth Drivers for Global Ligating Clips Market Unveiled in New Report - ResearchAndMarkets.com

Retrieved on: 
Monday, July 24, 2023
Surgery, Health, Medical Supplies, ASP, Internet, COVID-19, Ligation, Market access, CMO, Strategic planning, Blood, SWOT, Hemostasis, Patient, Investment, Patient safety, Reading, SWOT analysis, Region, Epidemiology, LIBOR market model, Procedure, Country, Retail, Birth control, Health care, Risk management

This report was built to visualize quantitative market trends within Wound Care Management therapeutic area.

Key Points: 
  • This report was built to visualize quantitative market trends within Wound Care Management therapeutic area.
  • Ligating clips are broadly divided into: Titanium ligating clips and Polymer ligating clips.
  • Key Inclusions of the market model are:
    Currently marketed Ligating Clips and evolving competitive landscape:
    Insightful review of the key industry trends.
  • Global, Regional and Country level market specific insights:
    Qualitative market specific information is available with global trends further broken down into regional trends.