How a ‘Chinese heart’ could get US blood pumping despite biotech decoupling

A groundbreaking medical device from China, the BrioVAD, is offering new hope to advanced heart failure patients across the United States. This fully magnetically levitated pump, roughly the size of a table tennis ball, is currently being tested in a nationwide clinical trial involving over 100 patients.

The BrioVAD functions as a left ventricular assist device (LVAD), designed to support the body's blood circulation when a patient's heart is too weakened to pump oxygen-rich blood effectively. Its significance is amplified by its origin: in 2024, it became the first active implantable medical device from China to gain approval from the U.S. Food and Drug Administration (FDA) for clinical trials within the United States.

The clinical trial, detailed in a paper published last August, is specifically designed to assess the safety and efficacy of the BrioVAD. The trial protocol aims to demonstrate that the Chinese device is non-inferior to the HeartMate 3, which is manufactured by Abbott. The HeartMate 3 currently holds the distinction of being the only LVAD commercially available in the U.S. market.

This development marks a notable step in international medical technology collaboration, potentially paving the way for wider adoption of Chinese-developed medical devices in the U.S. market, despite ongoing broader discussions about decoupling in the biotech sector.

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The trials were designed to evaluate the safety and efficacy of the BrioVAD by demonstrating non-inferiority to HeartMate 3.