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April 20, 2020
Cardionovum’s Aperto OTW Paclitaxel-Coated Balloon Approved in China for AV Access
April 20, 2020—Cardionovum announced that the company’s Aperto OTW over-the-wire paclitaxel-coated balloon for arteriovenous access has received market approval in China.
The device is a high-pressure drug-coated balloon (HPDCB) designed to treat obstructive lesions of native arteriovenous dialysis fistulae. Regulatory approval from China’s NMPA was based on the results of the APERTO AVF RCT CHINA clinical study of treatment in Chinese populations.
According to the company, APERTO AVF RCT CHINA is a multicenter, randomized controlled trial designed and performed with the highest quality standards. In a population of 161 patients, the study demonstrated statistical superiority of the Aperto HPDCB versus high-pressure plain old balloon angioplasty in freedom from restenosis at 6 months and better intervention-free survival of both the target lesion and target shunt at 12 months with equivalent safety. Also, patients treated with Aperto maintained patency for another 3 months, reported Cardionovum.
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