Sano Healthcare announced that the COMETIU self-inflating intracranial drug coating stent system and COMEX balloon microcatheter developed by the holding subsidiary Sano Shenchang have been certified as breakthrough medical devices by the US FDA. This product is the world's first intracranial atherosclerotic stenosis treatment product in the history of the US FDA, and the first domestic neurological interventional device product to receive breakthrough medical device certification from the US FDA. Obtaining this certification is another major milestone in the company's strategic process of innovative products for neurointerventional ischemic stroke treatment. It marks that the technological innovation and remarkable clinical advantages of the COMETIU self-inflating intracranial drug-coated stent system, the company is further recognized by authoritative international regulators. At the same time, the certification will strongly promote the company's nervous involvement in the international layout of innovative products, accelerate the company's globalization strategy process, significantly enhance the international popularity of the company's brand, and further consolidate the company's core competitiveness.

Zhitongcaijing · 08/06/2025 08:25
Sano Healthcare announced that the COMETIU self-inflating intracranial drug coating stent system and COMEX balloon microcatheter developed by the holding subsidiary Sano Shenchang have been certified as breakthrough medical devices by the US FDA. This product is the world's first intracranial atherosclerotic stenosis treatment product in the history of the US FDA, and the first domestic neurological interventional device product to receive breakthrough medical device certification from the US FDA. Obtaining this certification is another major milestone in the company's strategic process of innovative products for neurointerventional ischemic stroke treatment. It marks that the technological innovation and remarkable clinical advantages of the COMETIU self-inflating intracranial drug-coated stent system, the company is further recognized by authoritative international regulators. At the same time, the certification will strongly promote the company's nervous involvement in the international layout of innovative products, accelerate the company's globalization strategy process, significantly enhance the international popularity of the company's brand, and further consolidate the company's core competitiveness.