The device may be used in China for symptomatic patients at high or extreme risk of open-heart surgery, the company said.
The approval is based on clinical data for Evolut Pro from more than 32,000 patients; the data showed that use of the system translates to high survival rates, low stroke rates, and minimal paravalvular leaks, according to Medtronic. The company expects to begin marketing the system in China early this year.
In other Medtronic news, the company plans to acquire Affera, a Boston-based firm that designs and manufactures Prism-1, a cardiac mapping and navigation system, and Sphere-9, a catheter-based ablation technology for the treatment of cardiac arrhythmias and ablation therapy delivery. The acquisition is expected to close in the first half of Medtronic's 2023 fiscal year, the company said.
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