China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AcoArt Camellia, a paclitaxel-releasing coronary balloon dilation catheter. This medical device is now approved for the treatment of primary coronary artery disease in patients with vessel diameters ranging from 2.0mm to 2.75mm.
Clinical Efficacy and Safety of AcoArt Camellia
The efficacy and safety of AcoArt Camellia have been demonstrated through clinical trials. The clinical results indicate that at the primary endpoint, which is the rate of segmental diameter stenosis displayed by angiography at 9 months postoperatively, the AcoArt Camellia group showed a significantly lower percentage of 31.09% compared to the control group’s 40.32%. This data supports the effectiveness of AcoArt Camellia in treating primary coronary artery disease and its potential to improve patient outcomes.-Fineline Info & Tech
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