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Medtronic Announces Approval of the Evolut™ PRO TAVR System in China

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Monday, January 10, 2022
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DUBLIN, Jan. 10, 2022 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the National Medical Products Administration (NMPA) has approved the CoreValve™ Evolut™ PRO TAVR system for the treatment of severe aortic stenosis (AS) for symptomatic patients in China who are at high or extreme risk for open heart surgery. As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow). Full commercial launch is anticipated in early calendar year 2022.

Key Points: 
  • As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow).
  • The Evolut PRO TAVR system is the next generation of the clinically proven supra-annular CoreValve Evolut R system that provides industry-leading hemodynamic performance.
  • "The Evolut PRO TAVR system has shown impressive clinical outcomes and I look forward to seeing it benefit more patients throughout China."
  • The approval is based on data from high- and extreme-risk patients across Medtronic-sponsored studies and real-world registries with the CoreValve Evolut TAVR platform.