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QT Vascular's catheter gets US FDA clearance
CATALIST-LISTED QT Vascular on Monday said that it has received regulatory clearance from the United States Food and Drug Administration (FDA) for the sale and distribution of its Chocolate XD PTCA catheter.
The catheter is for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis to improve myocardial perfusion including in-stent restenosis, it said in a filing to the Singapore Exchange (SGX).
Said the group's chief executive Eitan Konstantino: "Chocolate XD is yet another of our devices utilising the Chocolate platform that is already commercial in the US. A drug coated version of the Chocolate PTCA is also in development, consistent with our vision of minimising the need for permanent implants placed in arteries. We intend to increase our focus on the coronary market and offer patients alternatives to conventional old balloons."
The Chocolate platform is designed to reduce vessel trauma by providing a balloon inflation that is predictable, controlled and uniform.
Chocolate XD is the most advanced catheter developed by the group for use in coronary arteries. It is now approved for use in de novo and restenotic lesions.