APERTO, Cardionovum’s paclitaxel-coated balloon for arterio-venous access, has received market approval for China, making it the first high pressure drug-coated balloon (DCB) available in China to treat obstructive lesions of native arterio-venous dialysis fistulae (AVF).
The approval was given based on the statistical superiority shown in a clinical study in Chinese populations: APERTO AVF RCT CHINA.
This is the first AVF randomised controlled study to archive statistical superiority of a high pressure DCB versus high-pressure plain balloon angioplasty. In a population of 161 patients, treatment with the device achieved superiority in freedom from restenosis at six months, and better intervention-free survival of both the target lesion and target shunt at 12 months with equivalent safety. Additionally, patients treated with APERTO maintained patency for another three months.