Recently, the innovative product Paclitaxel Coated PTA Balloon Catheter of TriReme Medical,LLC is approved by China NMPA.

This over-the-wire (OTW) balloon dilation catheter consists of a distal tip, balloon, nitinol constraining structure (CS), catheter shaft, stress diffusion tube, catheter hub, and radiopaque marker. The nitinol constraining structure is a ring-shaped external structure surrounding the balloon, with constraint wires distributed both axially and radially. The balloon surface is coated with paclitaxel, and propyl gallate serves as the coating excipient. This product is sterilized by ethylene oxide and is intended for single use, with a shelf life of 6 months. It is indicated for percutaneous transluminal angioplasty of primary stenotic lesions in the superficial femoral artery and popliteal artery, with lesion lengths not exceeding 180 mm and applicable vessel diameters of 4-7 mm. Pre-dilation of the lesions is required prior to use.

The NMPA will strengthen the post-marketing surveillance of the product to ensure the safe use of this medical device.