FDA approves clinical trials for QT Vascular’s Chocolate Touch

SINGAPORE (Sept 20): QT Vascular says it has been granted a conditional Investigational Device Exemption approval from the Food and Drug Administration to commence clinical trials for its Chocolate Touch drug-coated balloon.

The approval came after FDA conducted an extensive review of the technology, including its pre-clinical data, drug coating, bio safety, design feature and clinical data.

QT Vascular says the conditional IDE approval is a “significant step” toward receiving a full FDA approval.

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