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HEALTHCARE | Staff Reporter, Singapore

QT Vascular clinches full FDA approval to begin drug-coated balloon testing

Patient enrollment will begin early next year.

SGX-listed QT Vascular has been granted the full approval by the Food and Drug Administration to begin enrolling patients in the pivotal study of its new drug-coated balloon, known as Chocolate Touch.

The full IDE approval allows for enrollment up to 585 patients and up to 50 centers in the United States while additional patients may be enrolled in selected centers outside the US.

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