Acotec Scientific Holdings Limited has announced that it has received registration approval from the PRC National Medical Products Administration for its Coronary Over-the-Wire Balloon Dilatation Catheter, Jingyi. The device is indicated for dilating coronary artery or coronary artery bypass vessel stenosis to improve myocardial perfusion, with certain configurations also approved for post-stent dilation. The company highlighted that Jingyi features a semi-compliant balloon and an optimized delivery system designed for improved crossability and pushability, making it suitable for complex lesions. Acotec plans to commence marketing activities for the product in the Chinese market at an appropriate time. The company cautioned that successful commercialization is not guaranteed. No other organizations were mentioned as recipients of this regulatory approval.
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