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Cadrenal Therapeutics (Nasdaq: CVKD) has presented new data from the ARIES-HM3 trial at the ISHLT conference, showing the significant impact of anticoagulation quality in LVAD patients. The trial highlighted the deficiencies of warfarin and introduced tecarfarin, a novel VKA, as a potential replacement. Tecarfarin has received Orphan Drug Designation from the FDA for preventing thromboembolism in patients with mechanical circulatory support devices like LVADs.
The ARIES-HM3 data indicates a direct correlation between lower therapeutic range times (TTR) and higher bleeding events. The average patient experienced a 30% rate of serious bleeding even without aspirin in the regimen. Incremental improvements in TTR corresponded to significant reductions in bleeding rates, emphasizing the potential of tecarfarin to provide more stable anticoagulation compared to warfarin.
The data is under FDA review, and Cadrenal plans to pursue further pivotal trials to validate tecarfarin's effectiveness for LVAD patients.
Abbott has received FDA approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System, a dissolving stent for arteries below the knee. This breakthrough technology provides a new treatment option for people with chronic limb-threatening ischemia (CLTI) and peripheral artery disease (PAD). The system offers better outcomes compared to balloon angioplasty, which was the previous standard of care. The LIFE-BTK trial demonstrated that the Esprit BTK System reduces disease progression and improves medical outcomes. This innovation addresses the significant burden of disease and treatment options for patients with severe PAD.
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