Youmei Mu Si Coated Coronary Balloon Dilatation Catheter Receives NMPA Approval for Market Launch

Recently, the National Medical Products Administration (NMPA) approved the registration of the innovative product "Beauty Mos Coating Coronary Artery Balloon Dilation Catheter" produced by Jw Medical Systems Limited after review.

 

The Umiromycin-coated Coronary Balloon Dilatation Catheter consists of a balloon dilatation catheter and a drug coating on the balloon. The balloon catheter is composed of a balloon, distal tube, transition tube, and proximal tube, among others. The drug coating contains Umiromycin and polyethylene oxide carrier, with a drug dosage of 3μg/mm². The product is sterilized with ethylene oxide and is for single use. The product uses polyethylene oxide carrier to adhere Umiromycin to the surface of the balloon. The hydrophilic property of polyethylene oxide and the lipophilic property of Umiromycin enable the drug to be released from the balloon surface and quickly penetrate the vascular wall.

 

Drug-Coated Balloon as an intravascular drug delivery technology, can release effective therapeutic concentrations of drugs at the lesion site to address and treat in-stent restenosis and coronary heart disease interventions. This product is suitable for treating de novo coronary artery lesions with vessel diameters ranging from 2.0mm to 2.75mm, offering a new option for patients with small vessel disease.

 

　　MedicineThe regulatory authority will strengthen the post-marketing surveillance of this product to ensure patient safety in medical device usage.