Cadrenal Therapeutics (CVKD), developing tecarfarin, a late-stage, new-generation Vitamin K Antagonist oral and reversible anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, has been in discussions with Abbott (ABT) about Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. All patients with LVADs require lifelong anticoagulation to protect against thromboembolic events. In April 2024, tecarfarin received FDA Orphan Drug Designation to prevent blood clots and strokes in patients with implanted mechanical circulatory support devices such as LVADs. Currently, the only LVAD available in the United States is the HeartMate 3, manufactured by Abbott, which has been shown to be superior to all prior LVADs. Prior clinical studies provide evidence that tecarfarin yields improved AC quality, particularly in patients on multiple medications and those with impaired renal function, both of which are common in LVAD patients.
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