Beijing Balance Medical Secures NMPA Nod for Renatus Transcatheter Aortic Valve System

BEIJING—Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has received market approval from the National Medical Products Administration (NMPA) for its Renatus transcatheter aortic valve system. This in-house developed product is now approved for use in patients aged 70 years or older who are diagnosed with symptomatic, calcified, and severe degenerative aortic valve stenosis and are not candidates for routine surgical valve replacement after a comprehensive evaluation by the cardiac team and scoring system.

The Renatus valve system is described as the world’s first balloon dilation transcatheter aortic valve that operates with the same opening and closing mechanism as surgical biological valves. Under the guidance of medical imaging equipment, these biological valves can be selectively implanted into the human aortic valve annulus through various approaches using both long and short delivery systems. This innovative technology allows for the replacement of the original diseased aortic valve, catering to the clinical needs of patients with different pathways.

The approval of the Renatus valve system by the NMPA marks a significant advancement in the field of cardiovascular medicine, offering a new treatment option for elderly patients with aortic valve diseases. It underscores Beijing Balance Medical’s commitment to innovation in medical technology and its potential impact on improving patient outcomes. – Flcube.com

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