Hemostasis

Haemonetics Receives FDA Clearance for New TEG® 6s Global Hemostasis - HN Cartridge

Retrieved on: 
Thursday, April 4, 2024

This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.

Key Points: 
  • This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.
  • Haemonetics is planning to release the new Global Hemostasis-HN cartridge for TEG 6s system in the coming months.
  • Overall, over 5,500 clinical data points were used to demonstrate safety and effectiveness of the Global Hemostasis – HN assays.
  • "Our market-leading TEG 6s platform has helped Haemonetics make effective and efficient viscoelastic testing more accessible throughout the world," said Stewart Strong, President, Global Hospital at Haemonetics.

FDA Grants HemoSonics Expanded Use of its Critical Bleeding Management System with Special 510(k) Clearance

Retrieved on: 
Wednesday, April 3, 2024

DURHAM, N.C., April 3, 2024 /PRNewswire/ -- HemoSonics, a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge. HemoSonics' QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples. Today's announcement enables hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics' QStat Cartridge and the QPlus® Cartridge.

Key Points: 
  • HemoSonics' Quantra® Hemostasis Analyzer provides comprehensive blood analysis that details critical bleeding disorders and helps clinicians manage patients back into hemostasis.
  • DURHAM, N.C., April 3, 2024 /PRNewswire/ -- HemoSonics , a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge.
  • HemoSonics' QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples.
  • "The Quantra System now has the broadest range of FDA-cleared clinical indications of any cartridge-based viscoelastic testing system.

Guerbet strengthens its Executive Committee with two new appointments to consolidate its medium and long-term ambitions.

Retrieved on: 
Wednesday, March 13, 2024

Guerbet strengthens its Executive Committee with two new appointments to consolidate its medium and long-term ambitions.

Key Points: 
  • Guerbet strengthens its Executive Committee with two new appointments to consolidate its medium and long-term ambitions.
  • Villepinte, 11 march 2024: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, announces the strengthening of its management team with two appointments.
  • Christine Allard and Eva Ohlsson have joined the Group as senior Vice-President Public Affairs and Corporate Communications, and Senior Vice President Human Resources respectively.
  • Reporting directly to David Hale, Chief Executive Officer, they will both become members of Guerbet’s Executive Committee.

Olympus Distribution of EndoClot® Showing Steady Adoption in the U.S.

Retrieved on: 
Friday, March 1, 2024

EndoClot products are used by more than 700 accounts, including most of the country's top-ranked (by size) Integrated Delivery Networks (IDNs).

Key Points: 
  • EndoClot products are used by more than 700 accounts, including most of the country's top-ranked (by size) Integrated Delivery Networks (IDNs).
  • Since their launch, EndoClot products have been discussed in close to 20 relevant professional education courses offered via Olympus Continuum, providing physicians with peer-demonstrations of EndoClot technology capabilities during procedures.
  • "Olympus knew that EndoClot technology would be important to improving procedure efficiencies and contributing to improved patient outcomes," said Patrick Romano, Vice President, GI Business Unit Leader, Olympus Corporation of the Americas.
  • A new video highlighting use of the EndoClot PHS and EndoClot SIS has been developed to provide more information: https://www.youtube.com/watch?v=QlCaoiM2Eo0 .

BioMarin to Present ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) Data Highlighting Long-Term Durability at 2024 European Association for Haemophilia and Allied Disorders (EAHAD) Congress

Retrieved on: 
Tuesday, February 6, 2024

SAN RAFAEL, Calif., Feb. 6, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that new data on ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) will be presented at the 2024 European Association for Haemophilia and Allied Disorders (EAHAD) Congress, Feb. 6-9, 2024.

Key Points: 
  • SAN RAFAEL, Calif., Feb. 6, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that new data on ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) will be presented at the 2024 European Association for Haemophilia and Allied Disorders (EAHAD) Congress, Feb. 6-9, 2024.
  • The majority of participants maintained hemostasis, with only two of the seven participants in the study returning to regular prophylaxis, and no new safety signals emerged.
  • These data will be presented as a poster presentation from 6:30-7:30 p.m. Central European Time (CET) on Wednesday, Feb. 7.
  • "We are pleased to present data showing the impact of one-time treatment with ROCTAVIAN over seven years following the infusion, underscoring the potential of gene therapy to make a meaningful and long-lasting impact for people living with severe hemophilia A."

BIOLASE ENHANCES EDUCATION OFFERINGS IN 2024 DUE TO INCREASING DEMAND OF DENTAL LASER COURSES THROUGHOUT 2023

Retrieved on: 
Monday, January 8, 2024

LAKE FOREST, Calif., Jan. 8, 2024 /PRNewswire/ -- BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, has experienced growing demand for its robust educational offering and as a result has increased the number of dental laser courses planned for the first quarter of 2024. The full list of both in-person and virtual course options offered can be found through BIOLASE'S education web portal at Education.Biolase.com. Education.Biolase.com offers tailored education pathways through the Waterlase Academy and Epic Diode Academy.

Key Points: 
  • The BIOLASE Education Center has access to a surgical dental suite for live patient education and provides dental clinicians with a comfortable, engaging learning environment tailored to laser education.
  • To provide quality education in other specialized areas of dentistry, BIOLASE also offers courses in endodontics, periodontics, and pediatric dentistry.
  • To support diode laser education for dentists, the Epic Diode Academy is also offering multiple virtual surgical diode courses focused on clinical utilization of diode lasers.
  • BIOLASE plans to continue expanding its educational offerings through Education.Biolase.com, enabling dental clinicians to elevate their standard of dental care and improve patient outcomes through laser technology.

Octapharma Announces Availability of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, January 3, 2024

PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.

Key Points: 
  • The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
  • Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers.
  • "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future.
  • Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk.

In Vitro Diagnostics Analyzers Market Analysis Reveals Impressive Growth Forecast Through 2028 with Focus on Key Drivers and Trends - ResearchAndMarkets.com

Retrieved on: 
Friday, December 29, 2023

The increasing elderly population, growing incidence of chronic diseases, widening use of diagnostics for prevention and monitoring, and growing adoption of PoC testing are driving market growth.

Key Points: 
  • The increasing elderly population, growing incidence of chronic diseases, widening use of diagnostics for prevention and monitoring, and growing adoption of PoC testing are driving market growth.
  • Based on analyzer type, the market is categorized into immunoassay analyzers, clinical chemistry analyzers, hematology and hemostasis analyzers, molecular diagnostic analyzers and PoC analyzers.
  • The molecular analyzers segment, which held the third largest market share in 2022, is expected to show the highest CAGR, at 6.0%, during the forecast period.
  • The current report highlights the current and future market potential of in vitro diagnostics analyzers along with an analysis of the drivers, restraints, challenges, and emerging trends in the market.

Teleflex Announces First Patient Enrollment in ACCESS-MANTA™ Registry

Retrieved on: 
Thursday, November 16, 2023

The registry will include appropriate patient selection and proper vascular access.

Key Points: 
  • The registry will include appropriate patient selection and proper vascular access.
  • Enrolling at least 250 patients in up to 15 major TAVR institutions across the US and Canada, the ACCESS-MANTA™ Registry is an international, multicenter, prospective, observational, single-arm clinical registry.
  • “Large bore access site complications are recognized as morbid,1 driving increased costs and prolonged length-of-stay,2” said Teleflex Interventional Medical Director, Christopher Buller, MD.
  • “We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA™ Registry,” said Dr. Khera, Co-Global Principal Investigator.

FDA and EMA Accept Marstacimab Regulatory Submissions for the Treatment of Hemophilia A and B

Retrieved on: 
Monday, December 11, 2023

The European marketing authorization application (MAA) for marstacimab also passed validation and is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • The European marketing authorization application (MAA) for marstacimab also passed validation and is currently under review by the European Medicines Agency (EMA).
  • If approved in the U.S. and EU, marstacimab is expected to become the first once-weekly subcutaneous treatment for people living with hemophilia B and the first treatment administered as a flat dose for people living with hemophilia A or B.
  • For appropriate patients living with hemophilia A and B, the goal of this treatment is to prevent potentially life-threatening bleeds with a once-weekly, subcutaneous flat-dose administration.
  • The submissions for marstacimab are based on efficacy and safety data from the Phase 3 BASIS trial ( NCT03938792 ).