Acotec Scientific Holdings Ltd. has announced that it has received registration approval from the PRC National Medical Products Administration for its Sirolimus-Coated Coronary Balloon Dilatation Catheter, AcoArt Canna®. This approval marks a significant milestone for the company, allowing it to proceed with marketing activities in the PRC market when deemed appropriate. The AcoArt Canna® is designed for the dilatation treatment of de novo coronary artery bifurcation lesions with vessel diameters ranging from 2.0mm to 4.0mm. Clinical trials have demonstrated its efficacy and safety, with no statistically significant difference in diameter stenosis compared to the control group using paclitaxel-coated catheters. However, the company cautions that it may not ultimately be able to market the product.
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