China’s Tiny 90‑Gram Artificial Heart Wins EU Approval, Marks Global Breakthrough

CoreHeart’s Corheart 6 artificial heart has become the world’s smallest and lightest fully magnetic‑levitation pump, measuring just 34 mm in diameter and weighing 90 g. Unlike traditional devices that need separate coil sets for levitation and rotation, Corheart 6 uses a novel time‑division dynamic axial control system that drives and levitates the impeller with a single coil, cutting size and weight by about 30 % and 50 % respectively. The breakthrough earned the device the coveted EU CE‑MDR certification, the first time a Chinese Class III implantable heart has cleared Europe’s toughest regulatory hurdle. Since its Chinese market launch in 2023, more than 1,500 Corheart 6 implants have been performed across 150 hospitals. A two‑year follow‑up published in the European Journal of Cardio‑Thoracic Surgery reported an 86 % survival rate with no cases of pump thrombosis, device failure or hemolysis. The achievement signals a new phase in China’s medical‑device export story – moving from low‑cost consumables to high‑tech, brand‑driven implants. CoreHeart is now registering its biventricular and interventional heart systems in the United States, aiming to bring the miniaturized, minimally invasive solution to patients worldwide who need a bridge to transplant or long‑term cardiac support.

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