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QT Vascular has received CE marking clearance for its peripheral drug-coated balloon (Chocolate Touch) and coronary drug-coated balloon (Chocolate Heart). The company's Chocolate PTA Balloon Catheter received FDA clearance and was the first medical interventional product from Singapore to receive US FDA clearance. The Chocolate PTCA was also approved by FDA to treat patients' coronary arteries. The company was conducting a pivotal study (ENDURE Trial) for the Drug Coated Chocolate Touch Balloon, with patient enrollment in Germany and New Zealand, though enrollment was impacted by FDA concerns regarding paclitaxel-coated devices in 2019 and later by COVID-19.
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