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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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April 21, 2020

ESC Publishes Guidance for the Diagnosis and Management of Heart Disease During COVID-19 Pandemic

April 20, 2020

ACC Outlines Implications and Considerations for Thrombotic Disease Patients During COVID-19 Pandemic