FDA突破性设备！全球首款钛合金全人工心脏

Core Viewpoint - BiVACOR's Total Artificial Heart (TAH) has received breakthrough device designation from the FDA, aimed at providing long-term support for patients with end-stage biventricular heart failure, addressing a critical gap in heart transplant availability [2][4][5] Company Overview - BiVACOR, founded in 2008 and headquartered in Huntington Beach, California, is a clinical-stage medical device company developing a fully implantable magnetic levitation total artificial heart for long-term support of end-stage biventricular heart failure patients [13] Product Development - The TAH is the first implantable total artificial heart based on rotary pump technology, designed for long-term treatment of severe biventricular heart failure, with a size comparable to an adult fist and a weight of 512 grams [8][10] - The device utilizes magnetic levitation technology, which minimizes friction and mechanical wear, potentially extending its lifespan to at least ten years [10][11] - The TAH can pump over 12 liters of blood per minute from each side, accommodating the needs of patients who wish to engage in moderate exercise [11] Clinical Trials and Results - As of November 2024, five patients in the U.S. have received the TAH, providing up to one month of support while awaiting donor heart transplants, with no reported strokes or device-related complications [5][6] - The FDA has approved the expansion of the trial to include an additional 15 patients starting in late 2025, based on positive safety and performance data [5] Funding and Financial Support - BiVACOR has received multiple rounds of funding, including $13 million from the Australian government and $18 million in a Series B round from OneVentures [14]